The Budesonide in Babies (BiB) Trial
Public ClinicalTrials.gov record NCT04545866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Controlled Trial of Budesonide + Surfactant Versus Surfactant Alone in Extremely Preterm Infants ("The Budesonide in Babies (BiB) Trial")
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04545866
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 642 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- Up to 48 Hours
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2021 (Actual)
- Primary completion
- Sep 5, 2024 (Actual)
- Completion
- Dec 17, 2026 (Estimated)
- Last update posted
- Apr 15, 2026
2021 – 2026
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35249-7335 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Sharp Mary Birch Hospital for Women & Newborns | San Diego | California | 92123 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Northwestern Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Mississippi Medical Center - Children's of Mississippi | Jackson | Mississippi | 39216 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| RTI International | Durham | North Carolina | 27705 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | — |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Brown University - Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04545866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 15, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04545866 live on ClinicalTrials.gov.