drugset / Trial / NCT01039285

Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

NCT01039285

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.

Timeline

Start
2009-12
Primary completion
2021-09
Completion
2022-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Poractant alfa Other / unclassified 200 mg/kg Other