Long Term Effect of Palivizumab Immunization on Children Born <29w Gestation

Dario Prais 1,3 Eytan Kaplan 1 Gil Klinger 2,3 Ephraim Bar-Yishay 1 Meir Mei Zahav 1,3 Huda Mussaffi 1,3 Guy Steuer 1 Lea Sirota 2,3 Hannah Blau 1,3
1Pulmonary Institute, Schneider Children’s Medical Center
2Department of Neonatal Intensive Care, Schneider Children’s Medical Center
3Sackler Faculty of Medicine, Tel Aviv University
Background: Palivizumab reduces severity of RSV infection in premature infants and may decrease risk for long term respiratory disease.  
Aims: To assess the effect of palivizumab on respiratory morbidity at school-age for children born extremely premature.
Methods: Infants born <29w gestation were assessed at school age by questionnaire, spirometry, plethysmography, methacholine challenge, bronchodilator response and exhaled nitric oxide. Children born extremely premature prior to routine palivizumab administration ("controls") were age matched and compared to those who had received palivizumab prophylaxis during the 1st RSV season ("palivizumab")
Results: 63 subjects aged 8.9+0.7y were included: 30 “palivizumab” and 33 “controls”. Perinatal data (gestational age, birth weight, mechanical ventilation, O­2 support and % BPD) were similar in both groups.
During 1st 2y, recurrent wheezing was reported in 86% for “palivizumab” children vs. 73% “controls” (p=0.2,NS). However, a major difference was found in hospital admissions with respiratory diagnoses: 10 vs. 32 respectively (p=0.001); 33% vs. 70% were hospitalized at least once (p=0.005).
Pulmonary function test (%predicted) (mean±SD) was good in both groups: FVC 89±11 vs 89±12, FEV1 84±11 vs 84±13, FEF25-75  76±29 vs 78±28; TLC 105±13 vs 101±14; FeNO 13.5±14.8 vs 10.7±6.7 ppb (p=NS, all parameters). There was no difference in bronchial hyperreactivity at school age.
Subgroups of patients born <26w gestation or those with BPD were similar, when comparing “palivizumab” and “control” groups.
Conclusions: in our cohort, palivizumab dramatically reduced the number of hospitalizations during the first 2y of life, but no significant effect was observed on lung function at school age which was good for both cohorts.








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