Timing of Newborn Pulse Oximetry Screenings for Critical Congenital Heart Defects Before Discharge

RESEARCH

Timing of Newborn Pulse Oximetry Screenings for Critical Congenital Heart Defects Before Discharge Lynn Crouch, Karen Gabel Speroni, Ruth Ann Jones, Eileen P. MacDougall, and Marlon G. Daniel

Correspondence Lynn Crouch, MSN, RNC-OB, University of Maryland Shore Medical Center at Easton, 219 South Washington St., Easton, MD 21601-2912. [email protected]

ABSTRACT

Keywords CCHD CCHD screening and pulse oximetry infant newborn screening

Methods: Registered nurses (RNs) performed POS at 24 to 25 hours of age (POS 1) and at discharge but less than 48 hours of age (POS 2). Data related to critical congenital heart defects were collected.

Objective: To determine if there would be positive results from a second pulse oximetry screening (POS) completed for newborns at discharge at 28 to 48 hours of age in addition to the newborn POS completed at 24 to 25 hours of age. Design: Prospective descriptive research study. Setting: Rural, mid-Atlantic, 13-bed, level I hospital. Participants: Newborns (N ¼ 1,002) at 35 weeks’ gestation or older discharged from the newborn nursery.

Results: There were no positive POS results (O2 saturation # 90%) at POS 1 or POS 2, and no additional diagnostic tests were ordered as a result of POS. Although one full-term newborn had negative results at POS 1 and POS 2, the RN identified a murmur, and a subsequent echocardiogram was used to detect tetralogy of Fallot and pulmonary atresia. The RNs detected concerning conditions in 14 newborns that resulted in 28 additional tests, including echocardiograms (9), chest x-ray imaging (8), laboratory testing (7), electrocardiograms (3), and ultrasound imaging (1). Conclusions: The POS-positive result rate was 0 for newborns at POS 1 and POS 2. Therefore, our study findings supported Maryland’s mandate of one POS completed within 24 to 48 hours of birth. Nurses must continue to be vigilant about assessing newborns, including screening for critical congenital heart defects and congenital heart defects.

JOGNN, 45, 39–44; 2016. http://dx.doi.org/10.1016/j.jogn.2015.10.007 Accepted October 2015

Lynn Crouch, MSN, RNCOB, is a unit educator, Women’s and Children’s Services, University of Maryland Shore Medical Center, Easton, MD. Karen Gabel Speroni, PhD, RN, is a research consultant, University of Maryland Shore Medical Center, Easton, MD.

(Continued)

The authors report no conflict of interest or relevant financial relationships.

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ritical congenital heart defects (CCHD) account for 6% to 10% of all infant deaths (de Wahl Granelli et al., 2009). The seven major CCHDs are hypoplastic left heart syndrome, pulmonary atresia, tetralogy of Fallot, total anomalous pulmonary venous return, transposition of the great vessels, tricuspid atresia, and truncus arteriosus (Centers for Disease Control and Prevention [CDC], 2015). These account for 17% to 31% of all congenital heart diseases (CHDs), and most infants with these conditions die within the first year of life (CDC, 2015). Worldwide, approximately 8 per 1,000 infants are born with CHD (Hoffman, 2011), and of those 2.5 to 3.0 per 1,000 infants have CCHDs (Cuzzi & Bradshaw, 2011). In addition, 1 to 2 newborns per 1,000 live births have ductal-dependent circulation and need a patent ductus arteriosus for survival (de Wahl Granelli et al., 2009). Because of the hemodynamic compromise after constriction of the ductus,

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severe hypoxemia and acidosis occur and can lead to shock, organ damage, and death (Mahle et al., 2009). A prenatal midtrimester sonogram or initial provider physical examination of the newborn may not detect CCHD (Ewer et al., 2011). Because newborns with CCHD may display behavior thought to be normal, such as poor feeding and being sleepy or irritable, CCHDs are difficult to diagnose. For this reason, pediatricians and pediatric cardiologists who perform newborn physical examinations before discharge sometimes miss CCHD (Hoffman, 2011). Cyanosis of the newborn may not be visible to health care providers until the pulse oximetry level is at or below 80% (Altman, 2014). Newborns with undiagnosed CCHD may be discharged to home only to return to the emergency department in critical condition within a few days after discharge. Late diagnosis

ª 2016 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses. All rights reserved. Published by Elsevier Inc.

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RESEARCH

Newborn Pulse Oximetry Screenings for Critical Congenital Heart Defects Before Discharge

Pulse oximetry screening is noninvasive, painless, inexpensive, and cost effective; positive results indicate the need for further tests for critical congenital heart defects.

is associated with increased morbidity and mortality because of hypoxemia and organ damage (Mahle, Martin, Beekman, Morrow, & Section on Cardiology and Cardiac Surgery Executive Committee, 2012; Shah, 2012). Pulse oximetry screening (POS) is a noninvasive, painless, inexpensive, and cost-effective method to screen for CCHD (Cuzzi & Bradshaw, 2011). Health care resources used to screen and evaluate newborns for CCHD far outweigh cost of late detection and infant death (Mahle et al., 2009).

Ruth Ann Jones, EdD, MSN, RN, NEA-BC, is Director of Acute Care and Emergency Services, University of Maryland Shore Medical Center at Dorchester and Easton and University of Maryland Emergency Center, Queenstown, MD.

Based on findings from the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children and with strong backing from the American Heart Association and American Academy of Pediatrics (Mahle et al., 2009; Mahle et al., 2012; Shah, 2012), in 2011 Secretary of Health and Human Services Kathleen Sebelius recommended that pulse oximetry be added to the recommended uniform screening panel along with the current metabolic and hearing screenings (Kemper et al., 2011; Mahle et al., 2012; Shah, 2012). In May 2011, legislation was enacted for Maryland hospitals to implement POS. The Maryland Department of Health and Mental Hygiene was tasked with providing each hospital with a POS algorithm for conducting, tracking, and reporting outcomes and with an education program for staff and parents (Badawi & Blitzer, 2012). Thereafter, all Maryland hospitals were required to complete POS for all newborns at 24 to 48 hours of age. Based on these recommendations and mandates, the study site established a policy to screen newborns 24 to 48 hours old.

crucial time when the ductus arteriosis is closing and newborns with undetected CCHDs are at risk. Therefore, conducting the POS closer to discharge but not after 48 hours may help to detect CCHD and additional postductal heart anomalies. A further concern was that in the previous year at this site, eight newborns with CHD were transferred to a level III NICU; four needed immediate surgery. At a rural community hospital, resources are not always available or timely even when relationships with pediatric cardiologists and echocardiogram readings are in place. Confirming best practices to improve newborn outcomes was warranted. From an evidence-based practice perspective, research was needed to identify the number of newborns in whom CCHD and CHD would remain undetected after the 24-hour POS and before discharge or up to 48 hours of age. The study objective was to determine if there would be positive results from a second POS completed for newborns at discharge at 28 to 48 hours of age (POS 2), in addition to the newborn POS completed at 24 to 25 hours of age (POS 1). Secondary objectives were to determine the presence of CHDs and the need for follow-up testing based on results of POS.

Methods Design and Participants This prospective descriptive study received institutional review board approval from the study hospital. The study population consisted of newborns in a rural hospital located in the mid-Atlantic region of the United States. Although it has a level I, 13-bed nursery, mother–baby dyad care is used to promote family-centered care. Study inclusion criteria were as follows: gestational age older than 35 weeks, provision of informed consent for participation in this research study by biological parent of the newborn being tested, and parent able to communicate in English or through use of the hospital language line. The one exclusion criterion was a known diagnosis of pulmonary or cardiac complications or other comorbidity that would preclude completion of the 24-hour and 48-hour screenings.

Marlon G. Daniel, MPH, MHA, is a statistician, University of Maryland Shore Medical Center, Easton, MD.

We conducted a literature search in the PubMed/ National Center for Biotechnology Information Bookshelf, MEDLINE, and Nurse Proquest databases using the search terms newborn screening, infant, CCHD, CCHD screening, and pulse oximetry for years 2002 through 2014. We found no articles in which the authors compared outcomes in newborns screened at 24 hours versus at discharge (up to 48 hours of age). Annually, there are approximately 1,000 births at the study site, and nurses noted that most newborns were not seen by a health care provider until 2 days after discharge. This was of concern because this is a

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Eileen P. MacDougall, MSN, RNC-OB, is Manager of Women’s & Children’s Services, University of Maryland Shore Medical Center, Easton, MD.

Procedure All unit registered nurses (RNs) attended an inservice session led by the nurse investigators in which the study’s purpose, procedures (population inclusion criteria, algorithm to use, timing of POS, and need for accurate timely results), documentation requirements, and possible need of an additional probe were described. The probe used at POS 1 was saved and used again at POS

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RESEARCH

Crouch, L., Speroni, K. G., Jones, R. A., MacDougall, E. P., and Daniel, M. G.

Pulse oximeter screening algorithm for asymptomatic newborns in the nursery at 24 hours of age

<90% in right hand or foot

90% to 94% in right hand AND right foot OR >3% difference

POSITIVE RESULT

RESCREEN One hour

Newborn failed test 1. Consult RT 2. Nurse Assessment 3. Call Pediatrician

1. Consult RT

>95% in right hand AND right foot AND <3% difference

NEGATIVE RESULT Newborn passed test

90% to 94% in right hand AND right foot OR >3% difference

RESCREEN One hour 1. Consult RT 90% to 94% in right hand AND right foot OR >3% difference 1. Consult RT 2. Call Pediatrician

Figure 1. Procedure for Critical Congenital Heart Defect Screening. All pulse oximetry results are reported as percentage O2 saturation. RT ¼ respiratory therapist.

2 for cost savings. During the 14 months of data collection, story boards were used as refreshers and to report progress. The RNs conducted POS on newborns at two time points using the Masimo Radical 7 pulse oximeter (Masimo Corp., Irvine, CA). Based on hospital unit requirements, unit RNs were trained to use the oximeter by the manufacturer’s representative. The training included proper placement of sensors and trouble-shooting of the oximeter. Hospital protocol requires that the monitors be maintained and checked for accuracy, which is completed by the hospital’s biomedical department. The Masimo pulse oximeter with a disposable probe was used on the right hand and the right foot. We collected data on demographics, gestational age, date and time of POS, oxygen saturation at POS 1 for right hand and foot, oxygen saturation

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at POS 2 for right hand and foot, detection of critical heart defects and postductal defects (POS 1 and POS 2), follow-up testing needed based on results of POS (POS 1 and POS 2), disposition, and length of stay. A single data tool was used for each newborn. Data were collected at birth and before discharge. We followed the state’s algorithm and hospital policy for POS (Figure 1). Therefore, the research procedures included one additional POS and collection of study data at the second time point. The second POS time point was at discharge or between 28 and 48 hours of age, whichever occurred first. For purposes of this study, if the second time point was before 28 hours, the second POS was not conducted. The timing of the first POS was within each newborn’s first 24 to 25 hours of life. Data were collected for 14 months. This was done with the knowledge that the hospital has on

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RESEARCH

Newborn Pulse Oximetry Screenings for Critical Congenital Heart Defects Before Discharge

The positive result rate was 0 for newborns at the first screening (24 to 25 hours of age) and at the second screening (discharge at 28 to 48 hours of age).

Table 1: Demographics for Study Population (N [ 1,002) Demographics Gender, n (%)

average 1,000 births per year. Based on the CHD reported incidence of 8 per 1,000, (Hoffman, 2011), we determined that collecting all birth records for at least 1 year would give the study sufficient cases to be comparable to the incidence rate in the United States. Descriptive statistics such as means and frequencies were used to describe the characteristics of the study subjects. Incidence rates and prevalence ratios were calculated at POS 1 and POS 2. Data analysis was conducted using SAS version 9.3. Of the 1,108 newborns enrolled in this study, 1,002 completed the study, defined as completion of the screening at 24 to 25 hours of age (POS 1) and at 28 to 48 hours of age (POS 2). Sixteen newborns did not complete the study: 13 were discharged within 28 hours, 2 had echocardiograms ordered before POS 2, and 1 was transferred from the unit. There were 90 protocol deviations regarding POS timing, which precluded inclusion in the final analysis. There were no CCHDs in the protocol deviation population.

Results Of the 1,002 newborns who completed the study, most were female (54.0%) and White (61.4%) (Table 1). Average gestational age was 39.2 weeks, and average age at discharge or length of stay was 49.4 hours. The rate of positive POS results was 0 for newborns at POS 1 and at POS 2 (Table 2). There were no positive (O2 saturation < 90%) POS results. There were no additional diagnostic tests ordered as a result of POS. However, because RNs reported newborn physical conditions or detected murmurs, 28 additional tests were completed on 14 newborns, including echocardiograms (9), chest x-ray imaging (8), laboratory testing (7), electrocardiograms (3), and ultrasound imaging (1). Of the 1,002 newborns screened, five (0.5%) had cardiac anomalies; all were full term and had negative POS results. In these five infants, four CHDs were detected: two (0.2%) had patent ductus arteriosus that required follow-up from the health care provider, one (0.1%) had a patent foramen ovale that required follow-up from the neonatologist, and one (0.1%) had ventricular

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Female

539 (53.8)

Male

463 (46.2)

Race/Ethnicity, n (%) White

615 (61.4)

African American

237 (23.7)

Asian

12 (1.2)

Hispanic

131 (13.1)

Native American

2 (0.2)

Other

5 (0.5)

Gestational age, weeks (SD)

39.2 (1.3)

Average age/length of stay, hours (SD)

49.4 (13.7)

septal defects that required follow-up from the health care provider. The one CCHD detected was tetralogy of Fallot and pulmonary atresia that required cardiology follow-up. In the case of this infant, the RN identified a murmur during a nursing assessment, and an echocardiogram detected tetralogy of Fallot and pulmonary atresia. Symptoms were mild and delayed. This CCHD is called a pink tet; the right-to-left shunting is minimal and does not present with cyanosis until the ductus arteriosis closes.

Discussion In this descriptive study, the CCHD rate of 0 was less than expected and less than previously found

Table 2: Point of Screening Outcomes by Time Screened Point of Screening Screening 1 Screening 2 Outcomes Mean age, hours

N ¼ 1,002

N ¼ 1,002

Total N ¼ 1,002

24.2 (1.6)

42.12 (6.1)

—

98.7 (1.2)

98.7 (1.2)

98.7 (0.9)

99.0 (1.1)

98.9 (1.2)

98.8 (2.2)

(SD) Mean right hand pulse oximetry result, %O2 saturation (SD) Mean right foot pulse oximetry result, %O2 saturation (SD)

JOGNN, 45, 39–44; 2016. http://dx.doi.org/10.1016/j.jogn.2015.10.007

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Crouch, L., Speroni, K. G., Jones, R. A., MacDougall, E. P., and Daniel, M. G.

in the general population (Cuzzi & Bradshaw, 2011). However, the number of CHDs was consistent with findings of de Wahl Granelli et al. (2009) and Hoffman (2011). For the newborn with CCHD, presenting condition and/or presence of a murmur warranted additional diagnostic tests, not the CCHD POS results. The RN assessment of the newborn between POS 1 and POS 2 resulted in the identification of the murmur, and subsequent testing identified CCHD. Researchers have reported on false-positive rates that varied from 0.13% to 0.87%, the cost of diagnostic testing (de Wahl Granelli et al., 2009; Mahle et al., 2009; Riede et al., 2010), and increased parental anxiety (Powell et al., 2012). Diagnostic testing would include laboratory and radiology studies to rule out infection before advancing to an echocardiogram. The cost of the diagnostic testing, consultations, and added length of stay would vary by hospital and by country. Researchers have also shown the relationship between false-negative findings and poorer newborn outcomes caused by delays in detecting CHDs and CCHDs (Harden, Martin, & Bradshaw, 2013). In a prospective study of more than 20,000 newborns, the false-negative rate was 0.02%. Of six newborns with anomalies, four were identified through examination findings before discharge, but two were discharged to home and returned to the emergency department with symptoms (Ewer et al. 2011). The cost of NICU hospitalization, surgery, and lifetime care of a child with neurological damage or death can be devastating (Hoffman, 2011). Practitioners must be aware of the limitations of POS as a screening tool for CCHD. A limitation of this research is that the findings may not be generalizable for hospitals that are not at sea level, because the hospital where the research was conducted is at sea level. Investigators have suggested that altitude may influence POS results, because oxygen saturation may be diminished at higher altitudes (Kemper et al., 2011; Mahle et al., 2009). Also, newborns were discharged before 72 hours, the time period in which the ductus arteriosis closes. Lastly, a positive result of POS is such a rare event that more time and observations may be required, which was outside the scope of this study.

RESEARCH

It is important that nurses remain vigilant about newborn assessment, including screening for critical congenital heart defects and congenital heart diseases.

study findings supported our state mandate of one POS completed at 24 to 48 hours after birth. The POS does have limitations; therefore, a thorough clinical assessment is imperative. Physicians, advanced practice nurses, and nurses must work together to ensure that all dimensions of the newborn assessment are completed, communicated, and documented. Educating parents before discharge about CCHD signs and symptoms and when to notify their providers after discharge from the hospital are also important tools to enhance early identification of CCHDs.

Acknowledgment The authors thank Janyne Althaus, MD, MA, Lois Sanger, MLS, and Martin Atherton, DrPH, for their assistance with manuscript review.

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Conclusions The POS-positive result rate for CCHD was 0 for newborns at POS 1 and POS 2. Therefore, our

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000311216 Kemper, A., Mahle, W., Martin, G., Cooley, W., Kumar, P., Morrow, W., … Howell, R. (2011). Strategies for implementing screening for critical congenital heart disease. Pediatrics, 128(5), e1259–e1267.

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