The short-term outcome of a large cohort of very preterm infants treated with poractant alfa (Curosurf) for respiratory distress syndrome. A postmarketing phase IV study.

Abstract

OBJECTIVES:

To determine the effect of a porcine-derived lung surfactant, poractant alfa (Curosurf), on the respiratory outcome of very preterm infants with established neonatal respiratory distress syndrome (RDS), and to identify risk factors for severe bronchopulmonary dysplasia (BPD) in this population.

DESIGN:

A multicenter prospective longitudinal cohort study of 924 very preterm infants with RDS, born between 23 and 32 weeks gestation, and treated with at least one dose of poractant alfa during the first 48 hours of life.

RESULTS:

The median gestational age and the mean birthweight were 29 weeks and 1210 g, respectively; babies born at <28 weeks accounted for 27.1% of the cohort. Infants were treated with poractant alfa 7.9 hours after birth on average. Approximatively 32% of them required at least one additional dose. The mortality rate was 23.5%. The rates of survival without BPD at 28 days postnatal age and 36 weeks postmenstrual age were 38.9% and 54.0%, respectively. In the univariate analysis, factors associated with a higher risk of BPD at 36 weeks postmenstrual age (severe BPD) were low gestational age, low birthweight, poor response to the first dose, and the presence of pneumothorax, interstitial emphysema, pulmonary hemorrhage, patent ductus arteriosus requiring treatment, acquired pulmonary infection, or necrotizing enterocolitis. In the multivariate analysis, significant risk factors for severe BPD were low gestational age, low birthweight, and the presence of interstitial emphysema, pulmonary infection, or necrotizing enterocolitis.

CONCLUSION:

The rate of RDS-related complications in this high-risk cohort was comparable to the rates observed in the pivotal trials. In very premature infants treated with poractant alfa for established RDS, early barotrauma and postnatal local and/or systemic inflammation are strongly associated with the subsequent development of severe BPD.

• Authors: Géraldine Lamboley-Gilmert, Thierry Lacaze-Masmonteil, Neonatologists of the Curosurf Postmarketing French Study
• Journal: Paediatric drugs (Paediatr Drugs) Vol. 5 Issue 9 Pg. 639-45 ( 2003) ISSN: 1174-5878 [Print] Switzerland
• PMID: 12956620 (Publication Type: Clinical Trial, Clinical Trial, Phase IV, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Biological Products
• Phospholipids
• Pulmonary Surfactants
• poractant alfa

Topics

• Biological Products (adverse effects, therapeutic use)
• Cohort Studies
• Gestational Age
• Humans
• Infant, Newborn
• Infant, Premature
• Infant, Premature, Diseases (drug therapy)
• Phospholipids (adverse effects, therapeutic use)
• Product Surveillance, Postmarketing
• Prospective Studies
• Pulmonary Surfactants (adverse effects, therapeutic use)
• Respiratory Distress Syndrome, Newborn (drug therapy)
• Risk Factors
• Treatment Outcome