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The Budesonide in Babies (BiB) Trial

Study acronym: BiB
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Jan 7, 2026, no change to tracked fieldsv16-v17
  2. Results first posted: Nov 10, 2025
    • Secondary endpoints: details revised at 5 of 5 entries
    v15
  3. Primary endpoint revised
    • Enrollment target: estimated 1160 to confirmed 642
    • Secondary endpoints: 8 to 5
    v14
  4. 2 versions Re-verified since Feb 4, 2025, no change to tracked fieldsv12-v13
  5. Study completion date: Sep 30, 2026 to Dec 17, 2026v11
Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Primary completion date: Sep 30, 2025 to Sep 5, 2024
    • Study completion date: Sep 30, 2027 to Sep 30, 2026
    v9
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 19 of 19 sites
    v8
  4. Study sites: 16 to 19
    • Start date: Mar 15, 2021 to Apr 1, 2021
    v7
  5. Primary completion date: Mar 31, 2023 to Sep 30, 2025
    • Study completion date: Sep 2025 to Sep 30, 2027
    v6
  6. Site details revised at 6 of 16 sitesv5
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2021 to Mar 15, 2021
    • Site details revised at 16 of 16 sites
    v4
  8. Start date: Dec 2020 to Mar 1, 2021v3
  9. Start date: Sep 2020 to Dec 2020
    • Primary endpoint revised
    • Secondary endpoints revised (8)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
Related terms Bronchopulmonary Dysplasia, Premature Birth, Respiratory Distress Syndrome
Enrollment 642 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov