Clinical Trial

The Budesonide in Babies (BiB) Trial

Study acronym: BiB
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2020-09-04; most recent amendment 2026-04-13.
Status change: Recruiting → Active, Not Recruiting 2024-06-12
Status change: Not Yet Recruiting → Recruiting 2021-03-22
Trial Details
NCT Number NCT04545866
Lead Sponsor NICHD Neonatal Research Network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
Enrollment 642 participants
Start Date 2021-04-01
Primary Completion 2024-09-05 (estimated)
Study Completion 2026-12-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-15