The Budesonide in Babies (BiB) Trial (NCT04545866)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (10 items).
Location: University of Alabama — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (19 Sites)
- University of Alabama — Birmingham, Alabama
- Stanford University — Palo Alto, California
- Sharp Mary Birch Hospital for Women & Newborns — San Diego, California
- Emory University — Atlanta, Georgia
- Northwestern Lurie Children's Hospital of Chicago — Chicago, Illinois
- University of Iowa — Iowa City, Iowa
- University of Mississippi Medical Center - Children's of Mississippi — Jackson, Mississippi
- University of New Mexico — Albuquerque, New Mexico
- University of Rochester — Rochester, New York
- RTI International — Durham, North Carolina
- Duke University — Durham, North Carolina
- Cincinnati Children's Medical Center — Cincinnati, Ohio
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio
- Research Institute at Nationwide Children's Hospital — Columbus, Ohio
- University of Pennsylvania — Philadelphia, Pennsylvania
- Brown University - Women and Infants Hospital of Rhode Island — Providence, Rhode Island
- University of Texas Southwestern Medical Center at Dallas — Dallas, Texas
- University of Texas Health Science Center at Houston — Houston, Texas
- University of Utah — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.