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NCT04545866 · ClinicalTrials.gov registry record · Phase 3
The Budesonide in Babies (BiB) Trial
A Phase 3 study of Respiratory Distress Syndrome and Bronchopulmonary Dysplasia (BPD), sponsored by NICHD Neonatal Research Network.
- Active
- Registry status
- Phase 3
- Development phase
- 642
- Enrollment target
- 19
- Study locations
NCT04545866 is a Phase 3 study of Respiratory Distress Syndrome and Bronchopulmonary Dysplasia (BPD) that is active but no longer recruiting, run by NICHD Neonatal Research Network. The registered enrollment target is 642 participants, above the 154-participant average among 8 other Respiratory Distress Syndrome trials with a reported enrollment target (317% higher). The trial reports 19 study locations across 14 states.
The verdict
NCT04545866, a Phase 3 study of Respiratory Distress Syndrome and Bronchopulmonary Dysplasia (BPD), is active but no longer recruiting, sponsored by NICHD Neonatal Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 642 participants
- Enrollment target
- 19
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG budesonide (Pulmicort nebulizing suspension).
- DRUG surfactant (poractant alfa;Curosurf)
Study Locations (19)
Ohio
- Cincinnati Children's Medical Center - Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital - Cleveland
- Research Institute at Nationwide Children's Hospital - Columbus
California
- Stanford University - Palo Alto
- Sharp Mary Birch Hospital for Women & Newborns - San Diego
North Carolina
- RTI International - Durham
- Duke University - Durham
Texas
- University of Texas Southwestern Medical Center at Dallas - Dallas
- University of Texas Health Science Center at Houston - Houston
Alabama
- University of Alabama - Birmingham
Georgia
- Emory University - Atlanta
Illinois
- Northwestern Lurie Children's Hospital of Chicago - Chicago
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 642 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2026-12-17 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04545866
The ClinicalTrials.gov registry entry for NCT04545866 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 642 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 154-participant average among 8 other Respiratory Distress Syndrome trials with a reported enrollment target (317% higher). The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which budesonide (Pulmicort nebulizing suspension). is the first listed.
NCT04545866 reports 19 study locations spanning 14 distinct geographic areas - top geographies include Ohio, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04545866 about?
NCT04545866 is a clinical study titled "The Budesonide in Babies (BiB) Trial". 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 d...
What is the current status of trial NCT04545866?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 642 participants. The study started on 2021-04-01. Estimated completion is 2026-12-17.
What conditions does trial NCT04545866 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Bronchopulmonary Dysplasia (BPD), Prematurity; Extreme, Neonatal.
What interventions are being tested in trial NCT04545866?
The interventions under investigation include: budesonide (Pulmicort nebulizing suspension). (DRUG), surfactant (poractant alfa;Curosurf) (DRUG).
Who is sponsoring clinical trial NCT04545866?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04545866 being conducted?
This trial has 19 study locations across Alabama, California, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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