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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: Active Phase 3 study of Respiratory Distress Syndrome and Bronchopulmonary Dysplasia (BPD), sponsored by NICHD Neonatal Research Network.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A composite outcome for infants who were diagnosed with physiologic BPD or died by 36 weeks PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. Infants alive an in hospital are classified based on respiratory status at 36 week's PMA or by a room air weaning challenge performed between 36 and 37 weeks' PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks
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 |
What the registry record for NCT04545866 still lists
NCT04545866 is an interventional study that assigns participants to a tested intervention. The registered 642 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 8 other Respiratory Distress Syndrome trials with a reported enrollment target (317% higher).
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 lists 19 locations in 14 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04545866's enrollment target sits among peer trials
642 1st of 8 higher than 8 of 8 other Respiratory Distress Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Distress Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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