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The Budesonide in Babies (BiB) Trial
Sponsor: NICHD Neonatal Research Network
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.
Official title: Randomized Controlled Trial of Budesonide + Surfactant Versus Surfactant Alone in Extremely Preterm Infants ("The Budesonide in Babies (BiB) Trial")
Key Details
Gender
All
Age Range
Any - 48 Hours
Study Type
INTERVENTIONAL
Enrollment
642
Start Date
2021-04-01
Completion Date
2026-12-17
Last Updated
2026-01-26
Healthy Volunteers
No
Interventions
budesonide (Pulmicort nebulizing suspension).
The first dose of budesonide is 0.25 mg/kg in a volume of 1 ml/kg, for a total volume of 2.5 ml/kg of Curosurf + 1 ml/kg of budesonide. If the infant is to receive a second dose of study drug within 50 hours of birth, the dosage of Curosurf is 1.25 ml/kg for the second dose and 1 ml/kg of budesonide.
surfactant (poractant alfa;Curosurf)
The first dose of surfactant (poractant alfa; Curosurf) is 2.5 ml/kg. If the infant is to receive a second dose of study drug within 50 hours of birth, the dosage of Curosurf is 1.25 ml/kg for the second dose.
Locations (19)
University of Alabama
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
RTI International
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Brown University - Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States