The Budesonide in Babies (BiB) Trial

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Liveborn infants 22 0/7 - 28 6/7 weeks gestation or 401 - 1000 grams (inclusive) birth weight

• Clinical decision to give surfactant

• Less than or equal to 48 hours postnatal age

Exclusion Criteria:

• Terminal illness (heart rate < 100 beats per minute, unresponsiveness to resuscitation) or unlikely to survive as judged by the clinician

• Decision to redirect or limit support

• Use of surfactant before enrollment (first dose of surfactant must be study drug)

• Infant received systemic steroids prior to enrollment

• Use of indomethacin, either received by the mother within 24 hours prior to delivery,received by the infant prior to enrollment, or intent to administer to the infant for IVH prophylaxis or PDA management from enrollment up to 7 days of final dose of study drug

• Serious chromosomal abnormalities or major malformations

• Known congenital infections including, but not limited to, confirmed sepsis, congenital CMV, etc.

• Infants with a permanent neuromuscular condition that affects respiration

• Enrollment in a conflicting clinical trial