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Respiratory Syncytial Virus Prophylaxis With Palivizumab Is Not Associated With Improved Lung Function in Infants of
Ingmar Fortmann1, Marie-Theres Dammann1, Alexander Humberg1,2
1Department of Pediatrics, University of Lübeck, Lübeck, Germany.
Insights
Palivizumab immunoprophylaxis did not improve lung function or reduce respiratory infections in very low-birth weight infants (VLBWIs) by school age. This study found no long-term benefits for these high-risk children.
Area of Science:
- Pediatrics
- Neonatology
- Pulmonology
Background:
- Prematurity and respiratory syncytial virus (RSV) infection are key risk factors for long-term impaired lung function.
- Very low-birth weight infants (VLBWIs) are particularly susceptible to respiratory complications.
Purpose of the Study:
- To investigate the long-term effects of palivizumab immunoprophylaxis on lung function and bronchitis frequency in preterm infants.
- To assess if palivizumab administration in the first year of life impacts respiratory health at 5 to 6 years of age.
Main Methods:
- A German Neonatal Network cohort study followed VLBWIs (birth weight < 1,500 g) from 2009-2016.
- Children receiving at least five doses of palivizumab were compared to those who did not, with analyses stratified by bronchopulmonary dysplasia (BPD) and gestational age.
- Lung function (FVC, FEV1) and respiratory infection risk were analyzed at 5-6 years using regression models.
Main Results:
- Of 1,986 VLBWIs, 951 (48%) received palivizumab.
- Children with BPD had significantly lower FEV1, but palivizumab did not alter FEV1 in this group.
- No protective effects of palivizumab were observed for other lung function endpoints or in other risk groups.
Conclusions:
- Palivizumab immunoprophylaxis in VLBWIs is not associated with improved lung function at early school age.
- The study found no evidence that palivizumab reduces the frequency of respiratory tract infections in this population.
- Current immunoprophylaxis strategies may not offer sustained respiratory benefits for VLBWIs beyond infancy.
Background:
Prematurity and infection with respiratory syncytial virus (RSV) are major risk factors for impaired lung function beyond the neonatal period.
Research Question:
What are the long-term effects of palivizumab immunoprophylaxis in the first year of life on lung function and frequency of bronchitis episodes in 5- to 6-year-old preterm infants?
Study Design And Methods:
Preterm infants with a birth weight < 1,500 g (very low-birth weight infants [VLBWIs]) were enrolled in a German Neonatal Network cohort study between 2009 and 2016. Children were examined by a single follow-up team at 5 to 6 years of age. VLBWIs who received at least five doses of palivizumab were compared with children who never received palivizumab. Analyses were stratified by bronchopulmonary dysplasia (BPD) and gestational age. We analyzed FVC, FEV1, FEV1 to FVC ratio, and the risk of respiratory tract infections at 5 to 6 years of age via univariate analyses and linear and logistic regression models.
Results:
Of 1,986 VLBWIs with follow-up at 5 to 6 years of age, 951 infants (48%) received immunoprophylaxis with palivizumab. Children with BPD (n = 1,019) showed a much lower FEV1 than children without BPD (median FEV1 z score, -1.51 vs -1.09; P < .001). However, FEV1 in children with BPD was not altered by palivizumab (median FEV1 z score in 698 children with BPD who received palivizumab, -1.57 [interquartile range, -0.75 to -2.43] vs in 320 children with BPD who did not receive palivizumab, -1.37 [interquartile range, -0.69 to -2.25]; P = .1). As for FEV1, we did not find any protective effects of palivizumab for other end points or in other risk groups.
Interpretation:
Palivizumab immunoprophylaxis in VLBWIs is not associated with improved lung function or lower rates of respiratory tract infections in early school-age infants.
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