Overview

The Budesonide in Babies (BiB) Trial

Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will reduce the incidence of physiologic bronchopulmonary dysplasia (BPD) or death by 36 weeks' post-menstrual age in extremely preterm infants.
Phase:
Phase 3
Details
Lead Sponsor:
NICHD Neonatal Research Network
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Budesonide
Poractant alfa
Pulmonary Surfactants