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Palivizumab in infants with gestational age < or = 28 weeks and bronchopulmonary dysplasia
S Parmigiani1, A Ubaldi, C Capuano
1Dipartimento di Scienze Ginecologiche, Ostetriche e di Neonatologia Sezione di Puericultura e Medicina Neonatale, Università di Parma, Italia. steparmi@inwind.it
Insights
This study found that palivizumab, used for respiratory syncytial virus (RSV) prevention, showed no contraindications in premature infants with severe bronchopulmonary dysplasia (BPD). Further research is needed to confirm its efficacy in this vulnerable population.
Area of Science:
- Neonatology
- Pediatric Pulmonology
- Infectious Diseases
Background:
- Severe bronchopulmonary dysplasia (BPD) increases the risk of respiratory syncytial virus (RSV) infections in premature infants.
- Prophylactic palivizumab is used to prevent RSV, but its safety and efficacy in infants with severe BPD requiring respiratory support at discharge are not well-established.
Purpose of the Study:
- To evaluate the safety and preliminary efficacy of prophylactic palivizumab in infants born at or before 28 weeks' gestation with severe BPD requiring pharmacologic respiratory therapy at discharge.
Main Methods:
- A cohort of 11 infants (gestational age ≤28 weeks) with severe BPD received prophylactic palivizumab (15 mg/kg every 4 weeks, max 5 doses).
- These infants were compared to a control group of 8 similar infants who did not require discharge therapy and received no placebo.
- Data were collected on side effects and RSV infection rates during the November-March period.
Main Results:
- No significant side effects were observed in the palivizumab-treated group.
- No infant in either the treated or control group contracted RSV during the study period.
- Preliminary data suggest palivizumab is safe for this specific high-risk infant population.
Conclusions:
- Palivizumab appears to be safe for prophylactic use in infants born at or before 28 weeks' gestation with severe BPD requiring pharmacologic respiratory therapy at discharge.
- Further studies are necessary to definitively assess the efficacy of palivizumab in preventing RSV infection in this vulnerable group.
Abstract:
We report data from 11 patients < or = 28 weeks' gestation with severe bronchopulmonary dysplasia (BPD) prophylactically treated with palivizumab for prevention of respiratory syncytial virus (RSV) infection. All babies were receiving pharmacologic respiratory therapy at the moment of discharge from neonatal intensive care unit. Babies received 15 mg/kg i.m. palivizumab every 4 weeks to a max of 5 doses during the period November-March. We compared them with 8 similar infants that did not require therapy at discharge, nor were given any placebo. The treated infants did not present significant side effects. No baby in both groups was infected with RSV during the period of observation. We conclude from these preliminary data that palivizumab did not present contraindications in infants < or = 28 weeks' gestation with severe BPD requiring pharmacologic therapy at discharge. More data are required to evaluate efficacy to prevent RSV infection in these infants.
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