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In asymptomatic late preterm and term infants, with neonatal hypoglycaemia, is the administration of 40% glucose gel effective in establishing normoglycaemia and reducing neonatal admissions?: A literature review
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Review
In asymptomatic late preterm and term infants, with neonatal hypoglycaemia, is the administration of 40% glucose gel effective in establishing normoglycaemia and reducing neonatal admissions?: A literature review Colm Darby A R T I C LE I N FO
A B S T R A C T
Keywords: 40% Glucose gel Dextrose gel Transient neonatal hypoglycaemia Asymptomatic hypoglycaemia NICU admissions Normoglycaemia Breastfeeding
Introduction: Transient neonatal hypoglycaemia (TNH) is a common condition affecting newborn infants in homeostatic transition from maternal glucose supply to own metabolic adaptation. Objectives: To review published research after the cochrane systematic review in 2016 on the use of 40% glucose gel for the treatment of asymptomatic TNH. Design: Critical analysis was undertaken through a literature review and themes amongst the studies were categorised. Databases sources: Grey literature, trial documents and databases inclusive of CINAHL, Cochrane, Medline and PubMed were searched between April 2017 and February 2018. Findings: 40% glucose gel may reduce NICU admissions, reduce length of stay in hospital, reduce maternal and infant separation and decrease hospital expenditure for asymptomatic hypoglycaemic infants. Conclusion: Although with limitations, the studies add to the growing evidence of support for 40% glucose gel as a safe, simple and effective intervention for asymptomatic hypoglycaemic infants. Future large-scale studies may increase the evidence and support the development of a national protocol/guideline.
1. Introduction Transient neonatal hypoglycaemia is a common condition that affects approximately 5–15% of newborn infants (Cornblath et al., 2000; Hay et al., 2009). Problems can occur with the ability to regulate their BGL within the first 48 h (Mitanchez et al., 2015). According to Sharma et al. (2017) a failure in the counter-regulatory mechanism for management of low blood glucose can lead to neonatal hypoglycaemia within the first few hours of life. This risk increases if the infant is born preterm, small or large for gestation and infant of a diabetic mother or ill after birth (Harris et al., 2012). Management of TNH is important to prevent neurodevelopmental delay, brain injury and sensory impairment (Adamkin, 2011; Burns et al., 2008). With the increase in preterm births and maternal factors such as obesity and diabetes, the prevalence of neonatal hypoglycaemia is increasing (Chawanpaiboon et al., 2019; Nankervis et al., 2018). Amid an emerging evidence base for the management of TNH, debate continues on the definition of hypoglycaemia and the accepted safe threshold for
treatment (Harris et al., 2014; Dixon et al., 2017). A study carried out in England in 2015 surveyed 161 neonatal units to determine their definition of hypoglycaemia, with an 84% response success, 88% of units defined hypoglycaemia as a BGL < 2.6 mmol/l (Dixon et al., 2017). This definition of < 2.6 mmol/l concurs with the most common definition of neonatal hypoglycaemia in Australasian neonatal units in 2014 (Harris et al., 2014). 2. Management of neonatal hypoglycaemia The management of symptomatic and asymptomatic TNH is dependent on the infant's birth weight and gestational age (Harding et al., 2016) and initial management for late preterm and term infants' aims to focus upon the feeding options and monitoring for these infants. As neonatal hypoglycaemia can be a transient condition within the first 48 h, early management and monitoring is advocated as the gold standard approach for infants who are at risk of neonatal hypoglycaemia (Rozance and Hay, 2016). However, inconsistencies remain
Abbreviations: THN, Transient neonatal hypoglycaemia; BGL, Blood Glucose Level; ANNP, advanced neonatal nurse practitioner; IMF, infant milk formula; UNICEF, United Nations Children's Fund; NICU, neonatal intensive care unit; WHO, World Health Organisation; QI, quality improvement; BAPM, British Association of Perinatal Medicine; NHS, National Health Service E-mail address: [email protected]. https://doi.org/10.1016/j.jnn.2019.09.003 Received 29 May 2019; Received in revised form 5 September 2019; Accepted 5 September 2019 1355-1841/ Crown Copyright © 2019 Published by Elsevier Ltd on behalf of Neonatal Nurses Association. All rights reserved.
Please cite this article as: Colm Darby, Journal of Neonatal Nursing, https://doi.org/10.1016/j.jnn.2019.09.003
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4. Results
problematic as neonatal risk factors and hypoglycaemic thresholds vary on local, national and international level (Bromiker et al., 2017). If BGL remains low then the infant is often admitted to NICU for an escalation of care. This escalation may involve the use of intravenous (IV) glucose fluid, which involves a series of venepuncture and cannulation procedures to manage and monitor the effects of the medication. Admission to NICU leads to a separation of mother and infant, a possible delay in establishing breastfeeding and cost implications for the hospital (Makker et al., 2018). Conversely evidence suggests that the escalation of maternal concerns around asymptomatic TNH to healthcare providers may be overlooked. Hawdon et al. (2017) identify this as a growing concern in the management of these infants and possible cause of litigation. The separation of mother and infant has ethical considerations, as it is a fine balance of beneficence and non-maleficence between intervention and separation for escalation of care. In 2016 a Cochrane systematic review of the evidence was updated surrounding the use of 40% glucose gel as a recommended intervention for the management of TNH for infants who were at risk (Hegarty et al., 2017). Although there were only two studies in the review, there was supported for the use of the 40% glucose gel in managing TNH. Weston et al. (2016) acknowledged that the administration of glucose gel provided the opportunity for the infant and mother to remain together with decreased separation in an admission to a neonatal unit. The limited evidence from the review highlighted that the rates of breastfeeding were higher post discharge when the use of the glucose gel was utilised as the intervention for correcting the low BGL in conjunction with breastmilk as the milk choice. However, consideration is required as to the power of statistical value to the results as there is limited transferability to the study population due to the small sample size contrary to the high confidence interval of 95% (CI 1.01 to 1.18) suggesting it has high statistical power. With the focus of evidence-based practice (EBP) in neonatal care increasing, healthcare professionals should have a meticulous and judicious approach to assimilating the best current evidence (Horbar et al., 2017; Titler, 2006). This approach of appraising the evidence requires clinical expertise and maintaining advocacy for the patient, their values and respecting their input in the shared decision making process (Dunn et al., 2018). As clinical leaders, ANNPs arguably understand the importance of advancing neonatal care and developing safe, ethical and effective policies and procedures advocating the best evidence available (Anderson, 2018). Utilising this evidence equips an ANNP to have a pragmatic and holistic approach to their decisionmaking capability when improving care delivery (Elliot et al., 2017). This article will critically appraise the emerging evidence available through a literature review on the use of 40% glucose gel for the management of asymptomatic TNH for consideration for changing current practice in a general district hospital.
On assessment of the quality of the evidence, consideration was given to their study methodology and hierarchy of internal validity (Murad et al., 2016). With the absence of randomised controlled trials in the available research there is low hierarchical evidence with 2 retrospective cohort studies, 2 quality improvement initiatives and an audit. Within the literature search there were some professional opinions on their original studies and antedoctal evidence that reviewed or appraised studies but did not inform the evidence. Therefore, these were not considered as significantly informative to the assessment of evidence base. The audit trail (Fig. 1) demonstrates the gathering of the evidence for appraisal. The final number of articles for review was five. Appraisal tools included Critical Appraisal Skills Programme (CASP, 2017) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statements (STROBE, 2009). These tools were used to support the higher quality of reporting the strengths and limitations within each study while assessing validity and reliability of evidence. The studies were cross-referenced, and common themes were identified. The themes will structure the literature review and the appraisal of evidence. 5. Discussion of results from review 5.1. Definition of neonatal hypoglycaemia As evidenced in the varying threshold values, among the studies, inconsistencies in the initiation of interventions for asymptomatic TNH remain problematic. Stewart et al. (2016) and Ter et al. (2017) both utilise the definition of neonatal hypoglycaemia as a BGL < 2.6 mmol/l as justified in their studies with acknowledgement that this value is not associated with adverse neurodevelopmental outcomes (McKinlay et al., 2015; Weston et al., 2016). The accuracy of BGL testing differ between the studies, Ter et al. (2017) monitored a true blood glucose using the glucose oxidase method while Stewart et al. (2016) used a portable glucometer. However, Stewart et al. (2016) increased confidence within the study by reducing the variable of inaccurate results through accuracy testing of samples throughout the study with a glucose oxidase method. Reliability of handheld glucometer devices to gather accurate results was expressed in the BAPM framework for the identification and management of neonatal hypoglycaemia in full term infants (BAPM, 2017). Conversion is required when comparing the blood glucose values among the studies as both the UK (mmol/l) and US (mg/dl) standard units of measurement were utilised. For ease of interpretation of values the formula ‘mmol/l = mg/dl/18’ was used to uniform the units. For the studies that were carried out in the US there was acknowledgement to the disagreement in guideline advice between the Pediatric Endocrine Society (PES) (Thornton et al., 2015) and the American Academy of Pediatrics (AAP). The AAP define neonatal hypoglycaemia as a value less than 1.4 mmol/l (Committee of Fetus and Newborn and Adamkin, 2011) while PES advise intervention for TNH only at 2.7 mmol/l. However, these recommendations were not intended as an interpretation of the threshold for 40% glucose gel interventions. Therefore, it could be argued that the guidelines were for the intervention of rescue intravenous glucose only reducing the reliability of the protocol measures for interventional thresholds. Bennet et al. (2016) argue that the AAP guideline is not widely implemented within hospitals across the US due to the limited evidence supporting the lower value of 1.4 mmol/l and lack of studies demonstrating the neurodevelopmental outcomes associated with the recommended threshold (Kerstjens et al., 2012). However, the protocol implementation study by Bennet et al. (2016) monitored the 49 asymptomatic infants with a BGL < 1.4 mmol/l that were treated with glucose gel and identified only nine (18%) required admission to NICU that did not resolve with glucose gel intervention (Bennet et al., 2016). Previous practice would
3. Methodology A literature search was conducted between April 2017 and December 2018 using Grey literature, trial documents and databases inclusive of CINAHL, Cochrane, Medline and PubMed. Synonyms, keywords and search terms included glucose gel, dextrose gel, hypoglycaemia, hypoglycemia, newborn, infant, neonatal admission and NICU. Both spellings of hypoglycaemia were included as search terms to ensure unbiased language (Sommer et al., 2019). To carry out the successful literature review an inclusion and exclusion criteria was applied as presented in Table one (Boell and CecezKecmanovic, 2015). Only articles that were in English or had an English translation were selected to avoid translation costs. Although language bias could not be eliminated, consideration for translated articles was included to reduce the effect (Wang et al., 2015). The search was limited to the last 3 years in order to review and appraise the latest evidence following the cochrane review (Weston et al., 2016) (See Table 1). 2
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Table 1 Inclusion and exclusion criteria. Inclusion Criteria
Exclusion Criteria
1. 2. 3. 4. 5.
1. 2. 3. 4. 5.
Papers in English or translated to English. Studies carried out in developing countries Studies carried out since 2016 Studies that used glucose gel as an intervention. Studies carried out on humans
Papers not in English Studies carried out in underdeveloped countries Studies carried out before 2016. Studies that looked at prophylactic glucose gel administration Studies carried out on animals
Fig. 1. Audit trail of searches and elimination of articles.
life.
have involved admission of all 49 infants for escalation of care to NICU. As their evidence suggest 40% glucose gel is effective in correcting BGL less than 1.4 mmol/l and reducing NICU admissions. The inconsistencies in practice is not restricted to the US as a study carried out within England demonstrated that neonatal units had varying threshold ranges depending on the type of feed consumed or if the infant was born of a diabetic mother (Dixon et al., 2017). The lack of standardised clinical guidelines adhered to nationally lead to challenges when considering the evidence base for application to practice. Both Makker et al. (2018) and Rawat et al. (2016) utilised varying values depending on the age of the infant. Although the algorithms were displayed in their studies, there was a lack of justification for the rationale or evidence to support the varying values at different ages of
5.2. Normoglycemia Appreciation to the difference in ranges and intervention thresholds is required when interpreting the efficacy of 40% glucose gel to correct a BGL to an acceptable value within each study. Ter et al. (2017) reports 75% (n = 75) of those with TNH corrected their BGL with one or two administrations of glucose gel and 11% (n = 11) correcting with 3 or more doses. However, there is no indication to the breakdown of what number of infants fell within threshold of 3–6 doses as 6 doses was identified as the maximum within the 48-h period. Conversely identified in their study there was no difference in the proportion of infants 3
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glucose gel implementation. Arguably the education through the QI may have contributed to the effective management of infants after birth in preventing neonatal hypoglycaemia as evidenced in the absence of any infants with hypothermia in the post implementation group. Both the largest and smallest study demonstrated a 73% reduction in neonatal admission rates for TNH in their findings (Stewart et al., 2016; Bennet et al., 2016). However, Bennet et al. (2016) did not include any power calculation in their protocol implementation results and Stewart et al. (2016) only provided a P value for the number of admission days (p = 0.01) rather than for the number of admissions. Although Rawat et al. (2016) and Ter et al. (2017) did not provide confidence intervals, they provided strong evidence (p= < 0.01) in their retrospective chart audit studies on the positive impact that glucose gel has on reducing neonatal admissions for TNH. The largest completed study in the US on the use of glucose gel for the prevention of TNH recorded 57% reduction in the odds ratio of transfer to NICU in their study with a 95% confidence interval (Makker et al., 2018). Of those who received multiple glucose gel administrations for correction of asymptomatic TNH, the study found no correlation with the likelihood of admission with the number of glucose treatments (p = 0.78). However, there was no significant difference between the two groups that received IV dextrose prior to NICU admission (p = 0.84) but there was a significant decrease in the number admitted after receiving the 1st IV dextrose bolus when glucose gel was administered after for subsequent hypoglycaemia (p= < 0.001). The administration of IV dextrose prior to NICU admission is specific to this study and the hospital policy and needs consideration in the generalisability of the protocol application. Whilst the evidence appraised is limited, it has been demonstrated that glucose gel implementation groups within each study had a reduction in neonatal admissions for TNH ranging from 36% to 73%.
achieving normoglycemia with one or two glucose gel administrations when compared with the pre implementation group receiving IMF. Ter et al. (2017) and Stewart et al. (2016) did not reduce the length of time for rechecking the BGL after glucose gel administration and monitored pre feed BGL. The limitation of the study suggests BGL check frequency at 30–40 min post administration provides peak concentration levels and an accurate reflection BGL correction. Arguably the increased frequency of BGL checks could be deemed an unnecessary intervention as Ter et al. (2017) demonstrated the largest correction with the minimalist number of glucose gel administrations. However, caution is indicated when interpreting these results as the time period between checks (3hours-pre-feed checks) could indicate potential undetected neonatal hypoglycaemia. Although Stewart et al. (2016) did not record the total number of glucose gel administrations, the effectiveness of correcting BGL to ≥2.6 mmol/l was reflected through the 48% reduction in duration of monitoring from initial diagnosis of TNH to normoglycemia classified within the study as two consecutive BGL ≥2.6 mmol. Rawat et al. (2016) utilised a maximum a 3-dose threshold of glucose gel within their study and demonstrated a 38% response to glucose gel therapy with one dose only required, subsequently the average BGL of 3.0 mmol/l 1 h post administration indicates a successful return to normoglycemia. However, 42% (28 out of 66) of the infants that did not respond to the glucose gel required an IV bolus after the first gel administration. Conversely it could be argued that although this percentage appears high, the introduction of 40% glucose gel reduced the absolute risk for IV glucose therapy to 15.4% (95% confidence interval 7.32–23.76). The study did not detect any adverse outcomes or large fluctuations in BGL, similar findings from Bennet et al. (2016) reported no hyperglycaemia or rebound hypoglycaemia within the data. There was successful normoglycemia correction in the protocol implementation study by Bennet et al. (2016), demonstrated that 68% corrected after the 1st dose administration, 22% after the 2nd dose and 9% requiring three doses in total. Of those 26 infants that required 3 doses, 13 were admitted to NICU as neonatal hypoglycaemia persisted. Evidence displayed that glucose gel corrected 65% of the infants that presented with an initial BGL < 1.4 mmol/l avoiding NICU admission, suggestive of a successful glucose gel protocol implementation. However it could be argued that due to the low threshold (1.4 mmol/l) for neonatal hypoglycaemia there is a requirement for multiples doses of glucose gel to correct normoglycemia as evidence by Makker et al. (2018) with 45% that received 1 gel administration, 30% received 2 gels, 17% received 3 gels and 8% received 4 gels.
5.4. Breastfeeding The Department of Health and other international health associations are committed to improving breastfeeding across the population (Department of Health, 2018; Association of Women's Health, Obstetric and Neonatal Nurses, 2015). Institutions for example WHO and UNICEF Baby Friendly initiatives (BFI) provide support to improve short term and long term medical and neurodevelopment benefits, infant nutrition and adopt a supportive culture for breastfeeding (WHO/UNICEF, 2009). The benefits of breastfeeding for infants include significant reduction in gastrointestinal and respiratory tract infections, necrotising entercolitis, asthma, eczema, diabetes mellitus and food allergies (AAP, 2010). With some of the benefits highlighted it is important that policy, which may affect the breastfeeding rates within the 1st 6 months of life, are evidenced base with a view to support or improve breastfeeding. Emerging evidence suggests that glucose gel usage arguably negates the need for IMF supporting the UNICEF standards however; a substantial body evidence supports the effectiveness of IMF correcting asymptomatic TNH (Gorden, 2016; Moon, 2016; Korhonen and Lehtonen, 2014). Stewart et al. (2016) focused of improving breastfeeding rates with a BFI approach with QI project implementation demonstrated a reduction from 96% to 52% (24 vs 11) of infants receiving IMF. The reduced need and usage of IMF may have been a confounding variable in the improvement of breastfeeding with the shift in opinion that there was a necessity for the IMF as the intervention (Stewart et al., 2016). The small sample size impedes on the generalisation and transferability of the results due to the decreased efficacy of the data. However only this study continued to monitor exclusive breastfeeding rates post discharge to 3 months of age. Makker et al. (2018) acknowledged that monitoring breastfeeding post discharge would provide greater evidence of the impact of pre-discharge exclusivity on sustainability. They reported significant increase in exclusive breastfeeding in year 2 of their study compared to year one with an increase from 6% to 19% (22
5.3. Maternal infant separation/NICU admission Admission of an infant to a neonatal unit is often an unanticipated occurrence and can lead to traumatic experience in the postnatal period with potential to increase psychiatric symptoms for some parents (Grekin and O'Hara, 2014). Although none of this evidence reported qualitative data on the phenomenological effects that separation of an infant from their mother for admission to NICU, the evidence showed a significant reduction in the occurrence of separation. With some opinion data and user experience gathered by Stewart et al. (2016) as part of the pre-implementation group, there were no qualitative data in the post implementation group of the QI. Two of the papers recorded the admissions to NICU from a newborn baby nursery, which is a separate room beside a maternity ward where the infants sleep (Rawat et al., 2016; Makker et al., 2018). Without bedside care location, care in a newborn baby nursery could impact on maternal and infant bonding and as such separation effects may not be adequately represented in these papers. Encouragingly the practice among hospitals in the America has improved with bedside care increased through the Baby Friendly initiative (Barrera et al., 2018). Stewart et al. (2016) demonstrated through the QI for baby friendly support that 73% reduction in admissions for TNH occurred with 4
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time for the post implementation group when normoglycemia corrected would account for the similar length of time to the pre implementation group. Ter et al. (2017) reported the least effect on length of stay in their study (4.4 days vs 4.1 days, p = 0.55) with the introduction of 40% glucose gel but potential cost and resource reduction, although not calculated, would be present in the significant reduction in NICU admissions (29% vs 14%, p = 0.01). Conversely Stewart et al. (2016) demonstrated a reduction in mean length of stay by 34% (5.8 days vs 3.8 days) in addition to 83% decrease in the total number of admission days (228 vs 42). Although no cost saving was calculated by Stewart et al. (2016), evidence from all the studies suggests that 40% glucose gel protocol implementation for the management of TNH reduces the need for NICU admissions and length of stay for postnatal care resulting in less expenditure by the healthcare provider. Consideration to the positive impact on institutional expenditure is important both within the NHS and private section with transferable results.
vs 73, p < 0.001). The use of glucose gel as an intervention decreased the need for IMF providing early supportive measure to assist with sustaining breasting. However, caution is indicated in interpreting these results as other factors may have contributed to this increase for example increased support from lactation consultants, increased focus on breastfeeding and introduction of donor breastmilk to the hospital. The results from Bennet et al. (2016) were difficult to interpret regarding exclusive breastfeeding rates post QI protocol implementation, as there were no calculated breastfeeding rates in retrospective audit of records. The authors suggest that as practice prior to the protocol implementation was supplementation with IMF, for management of TNH, then the breastfeeding exclusivity rates would have been close to zero. The results demonstrated 49% success in exclusive breastfeeding outcomes at the point of discharge with the replacement of IMF with 40% glucose gel leading to a slightly lower percentage than women whose infant did not have TNH (58%). A secondary outcome for the Rawat et al. (2016) study showed an increase in exclusive breastfeeding outcome (p = 0.03) at the point of hospital discharge from 19% to 26%. In addition, greater improvement was demonstrated when glucose gel was combined with feeding than with feeding alone (p < 0.01). Although a maximum of 3 gels were utilised in this study before admission to NICU for IV glucose was required. However Ter et al. (2017) found no significant difference in feeding outcomes (exclusive breastfeeding, 94% vs. 95% and Breastfeeding and expressed breastmilk 5% vs 2%). Exclusive breastfeeding was not an outcome identified by the authors and attention to the retrospective data abstraction may limit the robustness of the data quality and transferability to practice.
5.6. Ethics No ethical approval was required or sought in order to perform the literature review. All studies excluding the QI protocol implementation by Bennet et al. (2016) obtained ethical approval from appropriate institutions. Although not all QI initiatives apply for ethical approval it can be considered that verbal consent, respect, privacy and protection from harm are ethical concerns when implementing a change approach in the absence of the participants being considered as research applicants (Fiscella et al., 2015). Conversely it could be argued that when a QI initiative is applied by a registered healthcare professional they are bound by professional conduct to adhere to ethical principles suggesting an inferred application of all ethical principles (General Medical Council, 2014; NMC, 2015).
5.5. Cost and length of stay in hospital While fixed costs such as hospital overheads and bed space for maternal and infant care in hospital can not be reduced, variable costs are the area that hospital administrators identify as possible sources of expense reduction within the current era of intense cost containment in healthcare (Bowers and Cheyne, 2016; Healthcare Financial Management Assessment, 2019). Furthermore, according to Brownson et al. (2017) a gap surrounds the role of neonatologists and healthcare staff in the economic consideration in EBP protocol development with consideration to effectiveness and efficiency. Not all of the studies identified cost as an outcome but rather identified that the introduction of glucose gel reduced the length of stay and reduced NICU admissions providing a source to decrease expenditure by hospitals. Greater focus was placed on the cost saving outcomes within the studies for those delivering private healthcare rather than NHS providers. Rawat et al. (2016) demonstrated an overall cost savings of $642,951 USD over the 6-month period with the implementation of the glucose gel protocol. Additionally, reduced physician and hospital charges were identified through the majority of the asymptomatic infant with TNH requiring only 1 dose. Bennet et al. (2016) suggest that nurses are in a perfect position to change practice with replicating their QI initiative and highlighting the benefit of 40% glucose gel in reducing cost and improving health outcomes to nurse and physician leads. The article provides guidance on financial auditing practice to monitoring cost savings on glucose gel implementation for replication of the QI protocol. Auditing financial expenditure and cost savings with reducing length of time for a patient in hospital improves justification in replicating the QI across other trusts and for future researchers. Not all cost savings were reflected through reduction in length of stay, as demonstrated by Makker et al. (2018) with no difference in length of stay between the pre implementation and post implementation group. However, as evidenced in their results the introduction of glucose gel decreased the study population expenditure by 51% (801,276 USD vs 387,688 USD) with a similar reduction in professional charges (117.835 USD vs 59,020 USD). Additional 24 h monitoring
5.7. Limitations Retrospective information gathering was carried out by all the studies, a methodology that is reliant on accuracy of record keeping and has potential for data transcription and collection errors resulting in potential for information bias (Althubaiti, 2016). The non-randomised and sequential nature of the studies increases the risk of selection bias however audit can be a valuable assistance to any institution with intentions to improve the delivery and quality of health care (Courtney and McCutcheon, 2010). As a single literature reviewer with publications in this field this can lead to interpretation bias of the main themes and information relevant to the proposed search question (Drucker et al., 2016). With limited appraisal experience as a reviewer there may be a limitation in the assessment of relevance of search results in the literature review. Although greater literature review experience improves judgement on article relevance assessment, awareness of the limitation improves the conscious bias effect with assurance that effective assessment was completed through judgement placed on abstracts rather than identified keywords (Cooper and Ribble, 1989). The utilisation of a guideline such as PRISMA (Preferred Reporting Items for Systematic Reviews and Meta Analysis) could have improved the selection process however, this guideline is focused on systematic reviews and meta-analysis while the hierarchy of results gather in the search was low and may not have been applicable (Liberati et al., 2009). Although publication of studies in multiple journals increases readership and dissemination of research this can lead to multiple publication bias that was considering in the search strategy with elimination of articles referencing the same study by the study authors (Fairfield et al., 2017). With the exception of Makker et al. (2018) and Rawat et al. (2016) the sample numbers in the other studies are relatively small in comparison to the prevalence of TNH occurring. The small sample size affects the quality of the results in detecting clinical differences, increasing the risk of type-2 error occurrence in identifying the statistical 5
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Appendix A. Supplementary data
significance for transferability of results (Columb and Atkinson, 2016). The unnecessary admission time post-completed treatment within the study by Makker et al. (2018) reduces the reliability of the data in generating valid results when comparing length of stays between the groups. With varying inclusion criteria amongst the studies, generalisation of the population is difficult when collating the information for appraisal. When the studies are appraised the criterion related validity of the protocols and their inclusion criteria reduces the type two validity of the studies. However, Ter et al. (2016) strengthened the criterion validity of their study with utilisation of the external measure of the Sugar Babies Trial (Harris et al., 2013) to inform their study on BGL frequency and measurable outcomes (Moule and Goodman, 2014). This reduced the confounding bias, which may increase the reliability of results with similar findings with protocol replication indicating a stable protocol in generating reliable results (Langford and Young, 2013). Furthermore the confounding variables within the protocols reduces the transferability of the protocols for replication in other institutions due to varying inclusion criteria, interventional thresholds, supplementary feeding options, frequency of BGL checks and the number of glucose gel interventions permitted within each protocol.
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Research techniques made simple: assessing risk of bias in systematic reviews. J. Investig. Dermatol. 136 (11), 109–114. Dunn, S.I., Cragg, B., Graham, I.D., Medves, J., Gaboury, I., 2018. Roles, processes, and outcomes of interprofessional shared decision-making in a neonatal intensive care unit: a qualitative study. J. Interprofessional Care 32 (3), 284–294. Elliott, E.C., Walden, M., Young, A., Symes, L., Fredland, N., 2017. The lived experience of nurse practitioners practicing within the Transformational Advanced Professional Practice Model: a phenomenological study. J Am Assoc Nurse Pract 29 (6), 324–332. Fairfield, C.J., Harrison, E.M., Wigmore, S.J., 2017. Duplicate publication bias weakens the validity of meta-analysis of immunosuppression after transplantation. World J. Gastroenterol. 23 (39), 7198–7200. https://doi.org/10.3748/wjg.v23.i39.7198. Fiscella, K., Tobin, J.N., Carroll, J.K., He, H., Ogedegbe, G., 2015. Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system. BMC Med. Ethics 16 (1), 63. General Medical Council, 2014. Good Medical Practice. General Medical Council, Manchester, Manchester. Gorden, A., 2016. Guidelines: Guideline for the Prevention and Management of Neonatal Hypoglycaemia GL359. Royal Berkshire NHS Foundation trust. Grekin, R., O'Hara, M.W., 2014. Prevalence and risk factors of postpartum posttraumatic stress disorder: a meta- analysis. Clin. Psychol. Rev. 34 (5) 389-340. Harding, J.E., Harris, D.L., Hegarty, J.E., Alsweiler, J.M., McKinlay, C.J., 2016. An emerging evidence base for the management of neonatal hypoglycaemia. Early Hum. Dev. 104, 51–56. Harris, D.L., Weston, P.J., Harding, J.E., 2012. Incidence of neonatal hypoglycaemia in
6. Discussion Weston et al. (2016) supported the use of 40% glucose gel as a safe, simple and effective intervention for the management of neonatal hypoglycaemia however, they advised that interpretation on generalisation of the evidence should be considered due to the small sample sizes and inclusion of only two studies in the systematic review. The influence of the review has been demonstrated through the continued study of the interventions evident in the literature review. Although the studies are not without limitations and some studies of low quality, the evidence builds upon the current systematic review and adds continued support that the use of 40% glucose gel is an intervention that can be replicated, although a greater number of doses were required in the studies there was no occurrence of rebound hypoglycaemia or adverse effects. 40% glucose gel has the potential benefit of clinical and cost effectiveness in reducing NICU admissions. This intervention assists in reducing maternal and infant separation leading to an environment that supports breastfeeding along with the removal of infant milk formula as an intervention. 7. Conclusion This evidence suggests, 40% glucose gel is an example of a population based management strategy, that when compared with previous audited practice of IMF or IV glucose, it results in a reduction in length of stay and subsequent cost reductions in hospital care. The literature review provides the support for future studies to increase the reliability of evidence through implementation of a multicentre randomised controlled trial to gather data for determining clinical significance and informing national guideline development. Ethics Ethical approval was not required to carry out the literature review. Conflicts of interest None. Funding None. 6
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Hospital Services NHS, Essex. Moules, P., Goodman, M., 2014. Nursing Research; an Introduction, second ed. Sage, London. Murad, M.H., Asi, N., Alsawas, M., Alahdad, F., 2016. New evidence pyramid. BMJ: Evid. Based Med. 21, 125–127. Nankervis, A., Price, S., Conn, J., 2018. Gestational diabetes mellitus: a pragmatic approach to diagnosis and management. AJGP 47 (7), 445–449. Nursing and Midwifery Council, 2015. The Code: Professional Standards of Practice and Behaviour for Nurses and Midwives. NMC, London. Rawat, M., Chandrasekharan, P., Turkovich, S., Barclay, N., Perry, K., Schroeder, E., Testa, L., Lakshminurusimha, S., 2016. Oral Dextrose gel reduces the need for intravenous dextrose therapy in neonatal hypoglycaemia. Biomed Hub 1 (3). Rozance, P.J., Hay, W.W., 2016. New approaches to management of neonatal hypoglycaemia. Matern Health Neonatol Perinatol 2, 3. https://doi.org/10.1186/s40748016-0031-z. Sharma, A., Davis, A., Shekhamat, P.S., 2017. Hypoglycemia in the preterm neonate: etiopathogenesis, diagnosis, management and long term outcomes. Transl. Pediatr. 6 (4), 335–348. Sommer, S., Beitze, T., Osuri, P., Rosfeld, E., 2019. Reducing language bias in nursing education: equipping educators. Teach. Learn. Nurs. 14 (1), 30–34. Stewart, C.E., Sage, E.L., Reynolds, P., 2016. Supporting “Baby Friendly”: a quality improvement initiative for the management of transitional neonatal hypoglycaemia. Arch. Dis. Child. Fetal Neonatal Ed. 101 (4), 344–347. Strengthening the Reporting of Observational Studies in Epidemiologys, 2009. STROBE Statement – checklist of items that should be included in reports of cohort studies. https://www.strobe-statement.org/fileadmin/Strobe/uploads/checklists/STROBE_ checklist_v4_cohort.pdf, Accessed date: 11 November 2018. Ter, M., Halibullah, I., Leung, L., Jacobs, S., 2017. Implementation of dextrose gel in the management of neonatal hypoglycaemia. J. Paediatr. Child Health 53, 408–411. Thornton, P.S., Stanley, C.A., De Leon, D.D., 2015. Pediatric Endocrine Society. Recommendations from the Pediatric Endocrine Society for evaluation and management of persistent hypoglycemia in neonates, infants, and children. J. Pediatr. 167 (2), 238–245. Titler, M.G., 2006. Developing an Evidence-Based Practice, sixth ed. Mosby, St. Louis, MO. Wang, Z., Brito, J.P., Tsapas, A., Griebeler, M.L., Alahdab, F., Murad, M.H., 2015. Systematic reviews with language restrictions and no author contact have lower overall credibility: a methodology study. Clin. Epidemiol. 7, 243–247. Weston, P.J., Harris, D.L., Battin, M., Brown, J., Hegarty, J.E., Harding, J.E., 2016. Oral dextrose gel for the treatment of hypoglycaemia in newborn infants. Cochrane Database Syst. Rev.(5). https://doi.org/10.1002/14651858.CD011027.pub2. CD011027. World Health Organization/United Nations Childrens Fund, 2009. Baby-friendly Hospital Initiative: Revised, Updated, and Expanded for Integrated Care, Section1–4. WHO. UNICEF and Well start International, Geneva.
babies identified as at risk. J. Pediatr. 161, 787–791. Harris, D., Weston, P., Signal, M., Chase, J., Harding, J., 2013. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double blind, placebo-controlled trial. Lancet 382, 2077–2083. Harris, D.L., Weston, P.J., Battin, M.R., Harding, J.E., 2014. A survey of the management of neonatal hypoglycaemia within the Australian and New Zealand Neonatal Network. J. Paediatr. Child Health 50 (10), 55–62. Hawdon, J.M., Beer, J., Sharp, D., Upton, M., 2017. Neonatal hypoglycaemia: learning from claims. Arch. Dis. Child. Fetal Neonatal Ed. 102, 110–115. Hay Jr., W.W., Raju, T.N.K., Higgins, R.D., Kalhan, S.C., Devaskar, S.U., 2009. Knowledge gaps and research needs for understanding and treating neonatal hypoglycaemia: workshop report from eunice kennedy shriver national institute of child health and human development. J. Pediatr. 155 (5), 612–617. https://dx.doi.org/10.1016/j. jpeds.2009.06.044. Healthcare Financial Management Assessment, 2019. NHS Corporate Governance Map. HFMA, Bristol. Hegarty, J.E., Harding, J.E., Crowther, C.A., Brown, J., Alsweiler, J., 2017. Orla dextrose gel for prevention of low blood glucose levels in newborn babies. Cochrane Database Syst. Rev. 2017 (7). https://doi.org/10.1002/14651858.CD012152.pub2. CD012152. Horbar, J.D., Edwards, E.M., Greenberg, L.T., 2017. Variation in performance of neonatal intensive care units in the United States. JAMA Pediatrics 171 (3), 164396. https:// doi.org/10.1001/jamapediatrics.2016.4396. Kerstjens, J.M., Bocca-Tjeertes, I.F., de Winter, A.F., Reijneveld, S.A., Bos, A.F., 2012. Neonatal morbidities and developmental delay in moderately preterm-born children. Pediatrics 130, 265–272. Korhonen, K., Lehtonen, L., 2014. Unnecessary and necessary in-hospital formula supplementation. J. Pediatr. 165, 877. Langford, R., Young, A., 2013. Making a Difference in Nursing Research. Pearson, London. Liberati, A., Altman, D.G., Tetzlaff, J., Mulrow, C., Gøtzsche, P.C., Ioannidis, J.P.A., Clarke, M., Devereaux, P.J., Kleijnen, J., Moher, D., 2009. The PRiSMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 339, b2700. https://doi.org/10. 1136/bmj.b2700. Makker, K., Alissa, R., Dudek, C., Travers, L., Smotherman, C., Hudak, M.L., 2018. Glucose gel in infants at risk for transitional neonatal hypoglycemia. Am. J. Perinatol. 35 (11), 1050–1056. McKinlay, C., Aisweiler, J., Ansell, J.M., Anstice, N.S., Chase, J.G., Gamble, G.D., Harris, D.L., Jacobs, R.J., Jiang, Y., Optom, N.P.B., Signal, M., Thompson, B., Wouldes, T.A., Yu, T.Y., Harding, J.E., 2015. Neonatal glycaemia and neurodevelopmental outcomes at 2 years. N. Engl. J. Med. 373, 1507–1518. Mitanchez, D., Yzdorczyk, C., Simeoni, U., 2015. What neonatal complications should the paediatrician be aware of in case of maternal gestational diabetes? WJD 6 (5), 734–743. Moon, S., 2016. Treatment of Neonatal Hypoglycaemia in the High-Risk Infant. Mid Essex
7
Contents lists available at ScienceDirect
Journal of Neonatal Nursing journal homepage: www.elsevier.com/locate/jnn
Review
In asymptomatic late preterm and term infants, with neonatal hypoglycaemia, is the administration of 40% glucose gel effective in establishing normoglycaemia and reducing neonatal admissions?: A literature review Colm Darby A R T I C LE I N FO
A B S T R A C T
Keywords: 40% Glucose gel Dextrose gel Transient neonatal hypoglycaemia Asymptomatic hypoglycaemia NICU admissions Normoglycaemia Breastfeeding
Introduction: Transient neonatal hypoglycaemia (TNH) is a common condition affecting newborn infants in homeostatic transition from maternal glucose supply to own metabolic adaptation. Objectives: To review published research after the cochrane systematic review in 2016 on the use of 40% glucose gel for the treatment of asymptomatic TNH. Design: Critical analysis was undertaken through a literature review and themes amongst the studies were categorised. Databases sources: Grey literature, trial documents and databases inclusive of CINAHL, Cochrane, Medline and PubMed were searched between April 2017 and February 2018. Findings: 40% glucose gel may reduce NICU admissions, reduce length of stay in hospital, reduce maternal and infant separation and decrease hospital expenditure for asymptomatic hypoglycaemic infants. Conclusion: Although with limitations, the studies add to the growing evidence of support for 40% glucose gel as a safe, simple and effective intervention for asymptomatic hypoglycaemic infants. Future large-scale studies may increase the evidence and support the development of a national protocol/guideline.
1. Introduction Transient neonatal hypoglycaemia is a common condition that affects approximately 5–15% of newborn infants (Cornblath et al., 2000; Hay et al., 2009). Problems can occur with the ability to regulate their BGL within the first 48 h (Mitanchez et al., 2015). According to Sharma et al. (2017) a failure in the counter-regulatory mechanism for management of low blood glucose can lead to neonatal hypoglycaemia within the first few hours of life. This risk increases if the infant is born preterm, small or large for gestation and infant of a diabetic mother or ill after birth (Harris et al., 2012). Management of TNH is important to prevent neurodevelopmental delay, brain injury and sensory impairment (Adamkin, 2011; Burns et al., 2008). With the increase in preterm births and maternal factors such as obesity and diabetes, the prevalence of neonatal hypoglycaemia is increasing (Chawanpaiboon et al., 2019; Nankervis et al., 2018). Amid an emerging evidence base for the management of TNH, debate continues on the definition of hypoglycaemia and the accepted safe threshold for
treatment (Harris et al., 2014; Dixon et al., 2017). A study carried out in England in 2015 surveyed 161 neonatal units to determine their definition of hypoglycaemia, with an 84% response success, 88% of units defined hypoglycaemia as a BGL < 2.6 mmol/l (Dixon et al., 2017). This definition of < 2.6 mmol/l concurs with the most common definition of neonatal hypoglycaemia in Australasian neonatal units in 2014 (Harris et al., 2014). 2. Management of neonatal hypoglycaemia The management of symptomatic and asymptomatic TNH is dependent on the infant's birth weight and gestational age (Harding et al., 2016) and initial management for late preterm and term infants' aims to focus upon the feeding options and monitoring for these infants. As neonatal hypoglycaemia can be a transient condition within the first 48 h, early management and monitoring is advocated as the gold standard approach for infants who are at risk of neonatal hypoglycaemia (Rozance and Hay, 2016). However, inconsistencies remain
Abbreviations: THN, Transient neonatal hypoglycaemia; BGL, Blood Glucose Level; ANNP, advanced neonatal nurse practitioner; IMF, infant milk formula; UNICEF, United Nations Children's Fund; NICU, neonatal intensive care unit; WHO, World Health Organisation; QI, quality improvement; BAPM, British Association of Perinatal Medicine; NHS, National Health Service E-mail address: [email protected]. https://doi.org/10.1016/j.jnn.2019.09.003 Received 29 May 2019; Received in revised form 5 September 2019; Accepted 5 September 2019 1355-1841/ Crown Copyright © 2019 Published by Elsevier Ltd on behalf of Neonatal Nurses Association. All rights reserved.
Please cite this article as: Colm Darby, Journal of Neonatal Nursing, https://doi.org/10.1016/j.jnn.2019.09.003
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4. Results
problematic as neonatal risk factors and hypoglycaemic thresholds vary on local, national and international level (Bromiker et al., 2017). If BGL remains low then the infant is often admitted to NICU for an escalation of care. This escalation may involve the use of intravenous (IV) glucose fluid, which involves a series of venepuncture and cannulation procedures to manage and monitor the effects of the medication. Admission to NICU leads to a separation of mother and infant, a possible delay in establishing breastfeeding and cost implications for the hospital (Makker et al., 2018). Conversely evidence suggests that the escalation of maternal concerns around asymptomatic TNH to healthcare providers may be overlooked. Hawdon et al. (2017) identify this as a growing concern in the management of these infants and possible cause of litigation. The separation of mother and infant has ethical considerations, as it is a fine balance of beneficence and non-maleficence between intervention and separation for escalation of care. In 2016 a Cochrane systematic review of the evidence was updated surrounding the use of 40% glucose gel as a recommended intervention for the management of TNH for infants who were at risk (Hegarty et al., 2017). Although there were only two studies in the review, there was supported for the use of the 40% glucose gel in managing TNH. Weston et al. (2016) acknowledged that the administration of glucose gel provided the opportunity for the infant and mother to remain together with decreased separation in an admission to a neonatal unit. The limited evidence from the review highlighted that the rates of breastfeeding were higher post discharge when the use of the glucose gel was utilised as the intervention for correcting the low BGL in conjunction with breastmilk as the milk choice. However, consideration is required as to the power of statistical value to the results as there is limited transferability to the study population due to the small sample size contrary to the high confidence interval of 95% (CI 1.01 to 1.18) suggesting it has high statistical power. With the focus of evidence-based practice (EBP) in neonatal care increasing, healthcare professionals should have a meticulous and judicious approach to assimilating the best current evidence (Horbar et al., 2017; Titler, 2006). This approach of appraising the evidence requires clinical expertise and maintaining advocacy for the patient, their values and respecting their input in the shared decision making process (Dunn et al., 2018). As clinical leaders, ANNPs arguably understand the importance of advancing neonatal care and developing safe, ethical and effective policies and procedures advocating the best evidence available (Anderson, 2018). Utilising this evidence equips an ANNP to have a pragmatic and holistic approach to their decisionmaking capability when improving care delivery (Elliot et al., 2017). This article will critically appraise the emerging evidence available through a literature review on the use of 40% glucose gel for the management of asymptomatic TNH for consideration for changing current practice in a general district hospital.
On assessment of the quality of the evidence, consideration was given to their study methodology and hierarchy of internal validity (Murad et al., 2016). With the absence of randomised controlled trials in the available research there is low hierarchical evidence with 2 retrospective cohort studies, 2 quality improvement initiatives and an audit. Within the literature search there were some professional opinions on their original studies and antedoctal evidence that reviewed or appraised studies but did not inform the evidence. Therefore, these were not considered as significantly informative to the assessment of evidence base. The audit trail (Fig. 1) demonstrates the gathering of the evidence for appraisal. The final number of articles for review was five. Appraisal tools included Critical Appraisal Skills Programme (CASP, 2017) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statements (STROBE, 2009). These tools were used to support the higher quality of reporting the strengths and limitations within each study while assessing validity and reliability of evidence. The studies were cross-referenced, and common themes were identified. The themes will structure the literature review and the appraisal of evidence. 5. Discussion of results from review 5.1. Definition of neonatal hypoglycaemia As evidenced in the varying threshold values, among the studies, inconsistencies in the initiation of interventions for asymptomatic TNH remain problematic. Stewart et al. (2016) and Ter et al. (2017) both utilise the definition of neonatal hypoglycaemia as a BGL < 2.6 mmol/l as justified in their studies with acknowledgement that this value is not associated with adverse neurodevelopmental outcomes (McKinlay et al., 2015; Weston et al., 2016). The accuracy of BGL testing differ between the studies, Ter et al. (2017) monitored a true blood glucose using the glucose oxidase method while Stewart et al. (2016) used a portable glucometer. However, Stewart et al. (2016) increased confidence within the study by reducing the variable of inaccurate results through accuracy testing of samples throughout the study with a glucose oxidase method. Reliability of handheld glucometer devices to gather accurate results was expressed in the BAPM framework for the identification and management of neonatal hypoglycaemia in full term infants (BAPM, 2017). Conversion is required when comparing the blood glucose values among the studies as both the UK (mmol/l) and US (mg/dl) standard units of measurement were utilised. For ease of interpretation of values the formula ‘mmol/l = mg/dl/18’ was used to uniform the units. For the studies that were carried out in the US there was acknowledgement to the disagreement in guideline advice between the Pediatric Endocrine Society (PES) (Thornton et al., 2015) and the American Academy of Pediatrics (AAP). The AAP define neonatal hypoglycaemia as a value less than 1.4 mmol/l (Committee of Fetus and Newborn and Adamkin, 2011) while PES advise intervention for TNH only at 2.7 mmol/l. However, these recommendations were not intended as an interpretation of the threshold for 40% glucose gel interventions. Therefore, it could be argued that the guidelines were for the intervention of rescue intravenous glucose only reducing the reliability of the protocol measures for interventional thresholds. Bennet et al. (2016) argue that the AAP guideline is not widely implemented within hospitals across the US due to the limited evidence supporting the lower value of 1.4 mmol/l and lack of studies demonstrating the neurodevelopmental outcomes associated with the recommended threshold (Kerstjens et al., 2012). However, the protocol implementation study by Bennet et al. (2016) monitored the 49 asymptomatic infants with a BGL < 1.4 mmol/l that were treated with glucose gel and identified only nine (18%) required admission to NICU that did not resolve with glucose gel intervention (Bennet et al., 2016). Previous practice would
3. Methodology A literature search was conducted between April 2017 and December 2018 using Grey literature, trial documents and databases inclusive of CINAHL, Cochrane, Medline and PubMed. Synonyms, keywords and search terms included glucose gel, dextrose gel, hypoglycaemia, hypoglycemia, newborn, infant, neonatal admission and NICU. Both spellings of hypoglycaemia were included as search terms to ensure unbiased language (Sommer et al., 2019). To carry out the successful literature review an inclusion and exclusion criteria was applied as presented in Table one (Boell and CecezKecmanovic, 2015). Only articles that were in English or had an English translation were selected to avoid translation costs. Although language bias could not be eliminated, consideration for translated articles was included to reduce the effect (Wang et al., 2015). The search was limited to the last 3 years in order to review and appraise the latest evidence following the cochrane review (Weston et al., 2016) (See Table 1). 2
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Table 1 Inclusion and exclusion criteria. Inclusion Criteria
Exclusion Criteria
1. 2. 3. 4. 5.
1. 2. 3. 4. 5.
Papers in English or translated to English. Studies carried out in developing countries Studies carried out since 2016 Studies that used glucose gel as an intervention. Studies carried out on humans
Papers not in English Studies carried out in underdeveloped countries Studies carried out before 2016. Studies that looked at prophylactic glucose gel administration Studies carried out on animals
Fig. 1. Audit trail of searches and elimination of articles.
life.
have involved admission of all 49 infants for escalation of care to NICU. As their evidence suggest 40% glucose gel is effective in correcting BGL less than 1.4 mmol/l and reducing NICU admissions. The inconsistencies in practice is not restricted to the US as a study carried out within England demonstrated that neonatal units had varying threshold ranges depending on the type of feed consumed or if the infant was born of a diabetic mother (Dixon et al., 2017). The lack of standardised clinical guidelines adhered to nationally lead to challenges when considering the evidence base for application to practice. Both Makker et al. (2018) and Rawat et al. (2016) utilised varying values depending on the age of the infant. Although the algorithms were displayed in their studies, there was a lack of justification for the rationale or evidence to support the varying values at different ages of
5.2. Normoglycemia Appreciation to the difference in ranges and intervention thresholds is required when interpreting the efficacy of 40% glucose gel to correct a BGL to an acceptable value within each study. Ter et al. (2017) reports 75% (n = 75) of those with TNH corrected their BGL with one or two administrations of glucose gel and 11% (n = 11) correcting with 3 or more doses. However, there is no indication to the breakdown of what number of infants fell within threshold of 3–6 doses as 6 doses was identified as the maximum within the 48-h period. Conversely identified in their study there was no difference in the proportion of infants 3
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glucose gel implementation. Arguably the education through the QI may have contributed to the effective management of infants after birth in preventing neonatal hypoglycaemia as evidenced in the absence of any infants with hypothermia in the post implementation group. Both the largest and smallest study demonstrated a 73% reduction in neonatal admission rates for TNH in their findings (Stewart et al., 2016; Bennet et al., 2016). However, Bennet et al. (2016) did not include any power calculation in their protocol implementation results and Stewart et al. (2016) only provided a P value for the number of admission days (p = 0.01) rather than for the number of admissions. Although Rawat et al. (2016) and Ter et al. (2017) did not provide confidence intervals, they provided strong evidence (p= < 0.01) in their retrospective chart audit studies on the positive impact that glucose gel has on reducing neonatal admissions for TNH. The largest completed study in the US on the use of glucose gel for the prevention of TNH recorded 57% reduction in the odds ratio of transfer to NICU in their study with a 95% confidence interval (Makker et al., 2018). Of those who received multiple glucose gel administrations for correction of asymptomatic TNH, the study found no correlation with the likelihood of admission with the number of glucose treatments (p = 0.78). However, there was no significant difference between the two groups that received IV dextrose prior to NICU admission (p = 0.84) but there was a significant decrease in the number admitted after receiving the 1st IV dextrose bolus when glucose gel was administered after for subsequent hypoglycaemia (p= < 0.001). The administration of IV dextrose prior to NICU admission is specific to this study and the hospital policy and needs consideration in the generalisability of the protocol application. Whilst the evidence appraised is limited, it has been demonstrated that glucose gel implementation groups within each study had a reduction in neonatal admissions for TNH ranging from 36% to 73%.
achieving normoglycemia with one or two glucose gel administrations when compared with the pre implementation group receiving IMF. Ter et al. (2017) and Stewart et al. (2016) did not reduce the length of time for rechecking the BGL after glucose gel administration and monitored pre feed BGL. The limitation of the study suggests BGL check frequency at 30–40 min post administration provides peak concentration levels and an accurate reflection BGL correction. Arguably the increased frequency of BGL checks could be deemed an unnecessary intervention as Ter et al. (2017) demonstrated the largest correction with the minimalist number of glucose gel administrations. However, caution is indicated when interpreting these results as the time period between checks (3hours-pre-feed checks) could indicate potential undetected neonatal hypoglycaemia. Although Stewart et al. (2016) did not record the total number of glucose gel administrations, the effectiveness of correcting BGL to ≥2.6 mmol/l was reflected through the 48% reduction in duration of monitoring from initial diagnosis of TNH to normoglycemia classified within the study as two consecutive BGL ≥2.6 mmol. Rawat et al. (2016) utilised a maximum a 3-dose threshold of glucose gel within their study and demonstrated a 38% response to glucose gel therapy with one dose only required, subsequently the average BGL of 3.0 mmol/l 1 h post administration indicates a successful return to normoglycemia. However, 42% (28 out of 66) of the infants that did not respond to the glucose gel required an IV bolus after the first gel administration. Conversely it could be argued that although this percentage appears high, the introduction of 40% glucose gel reduced the absolute risk for IV glucose therapy to 15.4% (95% confidence interval 7.32–23.76). The study did not detect any adverse outcomes or large fluctuations in BGL, similar findings from Bennet et al. (2016) reported no hyperglycaemia or rebound hypoglycaemia within the data. There was successful normoglycemia correction in the protocol implementation study by Bennet et al. (2016), demonstrated that 68% corrected after the 1st dose administration, 22% after the 2nd dose and 9% requiring three doses in total. Of those 26 infants that required 3 doses, 13 were admitted to NICU as neonatal hypoglycaemia persisted. Evidence displayed that glucose gel corrected 65% of the infants that presented with an initial BGL < 1.4 mmol/l avoiding NICU admission, suggestive of a successful glucose gel protocol implementation. However it could be argued that due to the low threshold (1.4 mmol/l) for neonatal hypoglycaemia there is a requirement for multiples doses of glucose gel to correct normoglycemia as evidence by Makker et al. (2018) with 45% that received 1 gel administration, 30% received 2 gels, 17% received 3 gels and 8% received 4 gels.
5.4. Breastfeeding The Department of Health and other international health associations are committed to improving breastfeeding across the population (Department of Health, 2018; Association of Women's Health, Obstetric and Neonatal Nurses, 2015). Institutions for example WHO and UNICEF Baby Friendly initiatives (BFI) provide support to improve short term and long term medical and neurodevelopment benefits, infant nutrition and adopt a supportive culture for breastfeeding (WHO/UNICEF, 2009). The benefits of breastfeeding for infants include significant reduction in gastrointestinal and respiratory tract infections, necrotising entercolitis, asthma, eczema, diabetes mellitus and food allergies (AAP, 2010). With some of the benefits highlighted it is important that policy, which may affect the breastfeeding rates within the 1st 6 months of life, are evidenced base with a view to support or improve breastfeeding. Emerging evidence suggests that glucose gel usage arguably negates the need for IMF supporting the UNICEF standards however; a substantial body evidence supports the effectiveness of IMF correcting asymptomatic TNH (Gorden, 2016; Moon, 2016; Korhonen and Lehtonen, 2014). Stewart et al. (2016) focused of improving breastfeeding rates with a BFI approach with QI project implementation demonstrated a reduction from 96% to 52% (24 vs 11) of infants receiving IMF. The reduced need and usage of IMF may have been a confounding variable in the improvement of breastfeeding with the shift in opinion that there was a necessity for the IMF as the intervention (Stewart et al., 2016). The small sample size impedes on the generalisation and transferability of the results due to the decreased efficacy of the data. However only this study continued to monitor exclusive breastfeeding rates post discharge to 3 months of age. Makker et al. (2018) acknowledged that monitoring breastfeeding post discharge would provide greater evidence of the impact of pre-discharge exclusivity on sustainability. They reported significant increase in exclusive breastfeeding in year 2 of their study compared to year one with an increase from 6% to 19% (22
5.3. Maternal infant separation/NICU admission Admission of an infant to a neonatal unit is often an unanticipated occurrence and can lead to traumatic experience in the postnatal period with potential to increase psychiatric symptoms for some parents (Grekin and O'Hara, 2014). Although none of this evidence reported qualitative data on the phenomenological effects that separation of an infant from their mother for admission to NICU, the evidence showed a significant reduction in the occurrence of separation. With some opinion data and user experience gathered by Stewart et al. (2016) as part of the pre-implementation group, there were no qualitative data in the post implementation group of the QI. Two of the papers recorded the admissions to NICU from a newborn baby nursery, which is a separate room beside a maternity ward where the infants sleep (Rawat et al., 2016; Makker et al., 2018). Without bedside care location, care in a newborn baby nursery could impact on maternal and infant bonding and as such separation effects may not be adequately represented in these papers. Encouragingly the practice among hospitals in the America has improved with bedside care increased through the Baby Friendly initiative (Barrera et al., 2018). Stewart et al. (2016) demonstrated through the QI for baby friendly support that 73% reduction in admissions for TNH occurred with 4
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time for the post implementation group when normoglycemia corrected would account for the similar length of time to the pre implementation group. Ter et al. (2017) reported the least effect on length of stay in their study (4.4 days vs 4.1 days, p = 0.55) with the introduction of 40% glucose gel but potential cost and resource reduction, although not calculated, would be present in the significant reduction in NICU admissions (29% vs 14%, p = 0.01). Conversely Stewart et al. (2016) demonstrated a reduction in mean length of stay by 34% (5.8 days vs 3.8 days) in addition to 83% decrease in the total number of admission days (228 vs 42). Although no cost saving was calculated by Stewart et al. (2016), evidence from all the studies suggests that 40% glucose gel protocol implementation for the management of TNH reduces the need for NICU admissions and length of stay for postnatal care resulting in less expenditure by the healthcare provider. Consideration to the positive impact on institutional expenditure is important both within the NHS and private section with transferable results.
vs 73, p < 0.001). The use of glucose gel as an intervention decreased the need for IMF providing early supportive measure to assist with sustaining breasting. However, caution is indicated in interpreting these results as other factors may have contributed to this increase for example increased support from lactation consultants, increased focus on breastfeeding and introduction of donor breastmilk to the hospital. The results from Bennet et al. (2016) were difficult to interpret regarding exclusive breastfeeding rates post QI protocol implementation, as there were no calculated breastfeeding rates in retrospective audit of records. The authors suggest that as practice prior to the protocol implementation was supplementation with IMF, for management of TNH, then the breastfeeding exclusivity rates would have been close to zero. The results demonstrated 49% success in exclusive breastfeeding outcomes at the point of discharge with the replacement of IMF with 40% glucose gel leading to a slightly lower percentage than women whose infant did not have TNH (58%). A secondary outcome for the Rawat et al. (2016) study showed an increase in exclusive breastfeeding outcome (p = 0.03) at the point of hospital discharge from 19% to 26%. In addition, greater improvement was demonstrated when glucose gel was combined with feeding than with feeding alone (p < 0.01). Although a maximum of 3 gels were utilised in this study before admission to NICU for IV glucose was required. However Ter et al. (2017) found no significant difference in feeding outcomes (exclusive breastfeeding, 94% vs. 95% and Breastfeeding and expressed breastmilk 5% vs 2%). Exclusive breastfeeding was not an outcome identified by the authors and attention to the retrospective data abstraction may limit the robustness of the data quality and transferability to practice.
5.6. Ethics No ethical approval was required or sought in order to perform the literature review. All studies excluding the QI protocol implementation by Bennet et al. (2016) obtained ethical approval from appropriate institutions. Although not all QI initiatives apply for ethical approval it can be considered that verbal consent, respect, privacy and protection from harm are ethical concerns when implementing a change approach in the absence of the participants being considered as research applicants (Fiscella et al., 2015). Conversely it could be argued that when a QI initiative is applied by a registered healthcare professional they are bound by professional conduct to adhere to ethical principles suggesting an inferred application of all ethical principles (General Medical Council, 2014; NMC, 2015).
5.5. Cost and length of stay in hospital While fixed costs such as hospital overheads and bed space for maternal and infant care in hospital can not be reduced, variable costs are the area that hospital administrators identify as possible sources of expense reduction within the current era of intense cost containment in healthcare (Bowers and Cheyne, 2016; Healthcare Financial Management Assessment, 2019). Furthermore, according to Brownson et al. (2017) a gap surrounds the role of neonatologists and healthcare staff in the economic consideration in EBP protocol development with consideration to effectiveness and efficiency. Not all of the studies identified cost as an outcome but rather identified that the introduction of glucose gel reduced the length of stay and reduced NICU admissions providing a source to decrease expenditure by hospitals. Greater focus was placed on the cost saving outcomes within the studies for those delivering private healthcare rather than NHS providers. Rawat et al. (2016) demonstrated an overall cost savings of $642,951 USD over the 6-month period with the implementation of the glucose gel protocol. Additionally, reduced physician and hospital charges were identified through the majority of the asymptomatic infant with TNH requiring only 1 dose. Bennet et al. (2016) suggest that nurses are in a perfect position to change practice with replicating their QI initiative and highlighting the benefit of 40% glucose gel in reducing cost and improving health outcomes to nurse and physician leads. The article provides guidance on financial auditing practice to monitoring cost savings on glucose gel implementation for replication of the QI protocol. Auditing financial expenditure and cost savings with reducing length of time for a patient in hospital improves justification in replicating the QI across other trusts and for future researchers. Not all cost savings were reflected through reduction in length of stay, as demonstrated by Makker et al. (2018) with no difference in length of stay between the pre implementation and post implementation group. However, as evidenced in their results the introduction of glucose gel decreased the study population expenditure by 51% (801,276 USD vs 387,688 USD) with a similar reduction in professional charges (117.835 USD vs 59,020 USD). Additional 24 h monitoring
5.7. Limitations Retrospective information gathering was carried out by all the studies, a methodology that is reliant on accuracy of record keeping and has potential for data transcription and collection errors resulting in potential for information bias (Althubaiti, 2016). The non-randomised and sequential nature of the studies increases the risk of selection bias however audit can be a valuable assistance to any institution with intentions to improve the delivery and quality of health care (Courtney and McCutcheon, 2010). As a single literature reviewer with publications in this field this can lead to interpretation bias of the main themes and information relevant to the proposed search question (Drucker et al., 2016). With limited appraisal experience as a reviewer there may be a limitation in the assessment of relevance of search results in the literature review. Although greater literature review experience improves judgement on article relevance assessment, awareness of the limitation improves the conscious bias effect with assurance that effective assessment was completed through judgement placed on abstracts rather than identified keywords (Cooper and Ribble, 1989). The utilisation of a guideline such as PRISMA (Preferred Reporting Items for Systematic Reviews and Meta Analysis) could have improved the selection process however, this guideline is focused on systematic reviews and meta-analysis while the hierarchy of results gather in the search was low and may not have been applicable (Liberati et al., 2009). Although publication of studies in multiple journals increases readership and dissemination of research this can lead to multiple publication bias that was considering in the search strategy with elimination of articles referencing the same study by the study authors (Fairfield et al., 2017). With the exception of Makker et al. (2018) and Rawat et al. (2016) the sample numbers in the other studies are relatively small in comparison to the prevalence of TNH occurring. The small sample size affects the quality of the results in detecting clinical differences, increasing the risk of type-2 error occurrence in identifying the statistical 5
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Appendix A. Supplementary data
significance for transferability of results (Columb and Atkinson, 2016). The unnecessary admission time post-completed treatment within the study by Makker et al. (2018) reduces the reliability of the data in generating valid results when comparing length of stays between the groups. With varying inclusion criteria amongst the studies, generalisation of the population is difficult when collating the information for appraisal. When the studies are appraised the criterion related validity of the protocols and their inclusion criteria reduces the type two validity of the studies. However, Ter et al. (2016) strengthened the criterion validity of their study with utilisation of the external measure of the Sugar Babies Trial (Harris et al., 2013) to inform their study on BGL frequency and measurable outcomes (Moule and Goodman, 2014). This reduced the confounding bias, which may increase the reliability of results with similar findings with protocol replication indicating a stable protocol in generating reliable results (Langford and Young, 2013). Furthermore the confounding variables within the protocols reduces the transferability of the protocols for replication in other institutions due to varying inclusion criteria, interventional thresholds, supplementary feeding options, frequency of BGL checks and the number of glucose gel interventions permitted within each protocol.
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6. Discussion Weston et al. (2016) supported the use of 40% glucose gel as a safe, simple and effective intervention for the management of neonatal hypoglycaemia however, they advised that interpretation on generalisation of the evidence should be considered due to the small sample sizes and inclusion of only two studies in the systematic review. The influence of the review has been demonstrated through the continued study of the interventions evident in the literature review. Although the studies are not without limitations and some studies of low quality, the evidence builds upon the current systematic review and adds continued support that the use of 40% glucose gel is an intervention that can be replicated, although a greater number of doses were required in the studies there was no occurrence of rebound hypoglycaemia or adverse effects. 40% glucose gel has the potential benefit of clinical and cost effectiveness in reducing NICU admissions. This intervention assists in reducing maternal and infant separation leading to an environment that supports breastfeeding along with the removal of infant milk formula as an intervention. 7. Conclusion This evidence suggests, 40% glucose gel is an example of a population based management strategy, that when compared with previous audited practice of IMF or IV glucose, it results in a reduction in length of stay and subsequent cost reductions in hospital care. The literature review provides the support for future studies to increase the reliability of evidence through implementation of a multicentre randomised controlled trial to gather data for determining clinical significance and informing national guideline development. Ethics Ethical approval was not required to carry out the literature review. Conflicts of interest None. Funding None. 6
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