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Use of palivizumab in neonates who do not meet the American Academy of Pediatrics Guidelines for respiratory syncytial virus prophylaxis
Early Human Development 85 (2009) S93–S100
Contents lists available at ScienceDirect
Early Human Development j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / e a r l h u m d ev
Selected abstracts of the 1st International Conference on Clinical Neonatology
Use of palivizumab in neonates who do not meet the American Academy of Pediatrics Guidelines for respiratory syncytial virus prophylaxis
Table 1 Results.
Paolo Manzoni, MariaLisa Leonessa, Paolo Galletto, Elena Gallo, Ugo Sala, Giovanna Gomirato, Daniele Farina Neonatology and Hospital NICU, S. Anna Hospital, Torino, Italy
Mean gestational age (weeks, m ± sd) Age at first dose (months, m ± sd) Mean number of administered doses (per infant and per year) (m ± sd) Years of prophylaxis per infant (Md) Compliance to enrolment Proportion of enrolled infants who completed the scheduled courses RSV-related hospitalizations
Background: AAP and Italian Neonatology Society (SIN) recommend palivizumab (PVZ) prophylaxis in infants at high-risk for severe RSV infection. We evaluated safety, effectiveness and compliance to PVZ program in neonates at increased RSV risk but who did not qualify for prophylaxis according to AAP–SIN Guidelines. Methods: Retrospective, 8-year cohort study from a large tertiary Italian NICU. RSV hospitalizations, adverse events, and compliance to prophylaxis program were compared between infants who qualified for PVZ according to AAP–SIN guidelines (GroupA, n = 461) and infants at increased risk of severe RSV disease for various underlying chronic diseases/conditions, and who received off-label, compassionate PVZ outside of guidelines (GroupB, n = 51). Results: GroupB included infants with inherited chromosomal syndromes (n= 6: partial chromosomic translocations, Poland, Cornelia DeLange syndromes); Down syndrome (n= 7); cystic fibrosis (n= 1); congenital neuromuscular disorders (n= 7: Steinert, Werdnig–Hoffman, Thomsen diseases [three were oxygen-dependent, two had tracheostomy); severe laryngomalacia with recurrent apnoea (n= 4); severe gastroesophageal reflux (n = 5: three were under 24-hourmonitoring for prior ALTE episodes); diaphragmatic herniation after surgery (n= 3); cerebral palsy with recurrent apnoeas (n= 6); severe immunity defects/inherited immunity disorders (n = 4: congenital HIV infection [two], DiGeorge, Wiskott–Aldrich syndromes [one each]); and infants >33 weeks g.a. but severely SGA (n= 8: mean birthweight = 945 g [±380]). PVZ administration was safe and well tolerated; no adverse events were reported. Compliance to enrolment was high and similar (92% in A vs.100% in B; p = 0.15); however, the proportion of enrolled infants who completed the scheduled courses was significantly higher in B than in A (96.1% vs. 86.0%; p = 0.03).The overall rate of RSV-related hospitalizations was very low (2.1%), and similar in both groups (2.2% in A vs. 2.0% in B; p = 0.99). Conclusions: Palivizumab is safe in vulnerable infants at high-risk of severe RSV infections but who fall outside of the current prophylaxis guidelines. Compliance with palivizumab prophylaxis programs is high among infants with underlying chronic diseases.
pii:S0378-3782(09)00155-8
Mean duration of stay in hospital, and (range)
All infants (n = 512)
Group A (n = 461)
Group B (n = 51)
p-value
31.0 (± 5.8)
29.0 (± 4.8)
36.1 (± 2.2)
<0.01
5.2 (± 4)
5.4 (± 4)
4.2 (± 4)
0.18
4.4 (± 2.1)
4.3 (± 2.2)
4.9 (± 1.8)
0.25
1.2 (1)
1.0 (1)
1.5 (1)
0.08
93.6% 89.5%
92.1% 86.0%
100% 96.1%
0.12 0.03
11/512 (2.1%) 5.4 (2–10)
10/461 (2.2%) 6 (2–10)
1/51 (2.0%) 7
0.99 0.33
doi:10.1016/j.earlhumdev.2009.08.028
Lutein and zeaxanthin supplementation in preterm infants in NICU: Preliminary data from a multicentre RCT Paolo Manzonia, Roberta Guardionea, Paolo Bonettib, Claudio Prioloa, Andrea Maestria, Mansoldo Caterinab, Paolo Bibanb, Giovanni Anselmettic, Daniele Farinaa a Neonatology and NICU, S. Anna Hospital, Torino, Italy b Paediatric/Neonatal Intensive Care Unit, Division of Paediatrics, Azienda Ospedaliera, Verona, Italy c Referral Center for ROP of Piedmont, Torino, Italy
Background: Preterm infants are at high risk of oxidative stressinduced damage and diseases, including severe multifactorial outcomes of prematurity such as ROP, NEC and BPD. Human milk feedings of preterms is speculated having a protective role towards these diseases, namely against ROP and NEC. The carotenoids (lutein, b-carotene, and zeaxanthin) are a family of polyene, lipophilic molecules found in human milk but not in formulas. These molecules might account for the protective role of human milk, providing protection against both light-induced and metabolic oxidative
Contents lists available at ScienceDirect
Early Human Development j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / e a r l h u m d ev
Selected abstracts of the 1st International Conference on Clinical Neonatology
Use of palivizumab in neonates who do not meet the American Academy of Pediatrics Guidelines for respiratory syncytial virus prophylaxis
Table 1 Results.
Paolo Manzoni, MariaLisa Leonessa, Paolo Galletto, Elena Gallo, Ugo Sala, Giovanna Gomirato, Daniele Farina Neonatology and Hospital NICU, S. Anna Hospital, Torino, Italy
Mean gestational age (weeks, m ± sd) Age at first dose (months, m ± sd) Mean number of administered doses (per infant and per year) (m ± sd) Years of prophylaxis per infant (Md) Compliance to enrolment Proportion of enrolled infants who completed the scheduled courses RSV-related hospitalizations
Background: AAP and Italian Neonatology Society (SIN) recommend palivizumab (PVZ) prophylaxis in infants at high-risk for severe RSV infection. We evaluated safety, effectiveness and compliance to PVZ program in neonates at increased RSV risk but who did not qualify for prophylaxis according to AAP–SIN Guidelines. Methods: Retrospective, 8-year cohort study from a large tertiary Italian NICU. RSV hospitalizations, adverse events, and compliance to prophylaxis program were compared between infants who qualified for PVZ according to AAP–SIN guidelines (GroupA, n = 461) and infants at increased risk of severe RSV disease for various underlying chronic diseases/conditions, and who received off-label, compassionate PVZ outside of guidelines (GroupB, n = 51). Results: GroupB included infants with inherited chromosomal syndromes (n= 6: partial chromosomic translocations, Poland, Cornelia DeLange syndromes); Down syndrome (n= 7); cystic fibrosis (n= 1); congenital neuromuscular disorders (n= 7: Steinert, Werdnig–Hoffman, Thomsen diseases [three were oxygen-dependent, two had tracheostomy); severe laryngomalacia with recurrent apnoea (n= 4); severe gastroesophageal reflux (n = 5: three were under 24-hourmonitoring for prior ALTE episodes); diaphragmatic herniation after surgery (n= 3); cerebral palsy with recurrent apnoeas (n= 6); severe immunity defects/inherited immunity disorders (n = 4: congenital HIV infection [two], DiGeorge, Wiskott–Aldrich syndromes [one each]); and infants >33 weeks g.a. but severely SGA (n= 8: mean birthweight = 945 g [±380]). PVZ administration was safe and well tolerated; no adverse events were reported. Compliance to enrolment was high and similar (92% in A vs.100% in B; p = 0.15); however, the proportion of enrolled infants who completed the scheduled courses was significantly higher in B than in A (96.1% vs. 86.0%; p = 0.03).The overall rate of RSV-related hospitalizations was very low (2.1%), and similar in both groups (2.2% in A vs. 2.0% in B; p = 0.99). Conclusions: Palivizumab is safe in vulnerable infants at high-risk of severe RSV infections but who fall outside of the current prophylaxis guidelines. Compliance with palivizumab prophylaxis programs is high among infants with underlying chronic diseases.
pii:S0378-3782(09)00155-8
Mean duration of stay in hospital, and (range)
All infants (n = 512)
Group A (n = 461)
Group B (n = 51)
p-value
31.0 (± 5.8)
29.0 (± 4.8)
36.1 (± 2.2)
<0.01
5.2 (± 4)
5.4 (± 4)
4.2 (± 4)
0.18
4.4 (± 2.1)
4.3 (± 2.2)
4.9 (± 1.8)
0.25
1.2 (1)
1.0 (1)
1.5 (1)
0.08
93.6% 89.5%
92.1% 86.0%
100% 96.1%
0.12 0.03
11/512 (2.1%) 5.4 (2–10)
10/461 (2.2%) 6 (2–10)
1/51 (2.0%) 7
0.99 0.33
doi:10.1016/j.earlhumdev.2009.08.028
Lutein and zeaxanthin supplementation in preterm infants in NICU: Preliminary data from a multicentre RCT Paolo Manzonia, Roberta Guardionea, Paolo Bonettib, Claudio Prioloa, Andrea Maestria, Mansoldo Caterinab, Paolo Bibanb, Giovanni Anselmettic, Daniele Farinaa a Neonatology and NICU, S. Anna Hospital, Torino, Italy b Paediatric/Neonatal Intensive Care Unit, Division of Paediatrics, Azienda Ospedaliera, Verona, Italy c Referral Center for ROP of Piedmont, Torino, Italy
Background: Preterm infants are at high risk of oxidative stressinduced damage and diseases, including severe multifactorial outcomes of prematurity such as ROP, NEC and BPD. Human milk feedings of preterms is speculated having a protective role towards these diseases, namely against ROP and NEC. The carotenoids (lutein, b-carotene, and zeaxanthin) are a family of polyene, lipophilic molecules found in human milk but not in formulas. These molecules might account for the protective role of human milk, providing protection against both light-induced and metabolic oxidative