FindMyKOL
Clinical trialNCT04545866Active, not recruitingPhase 3Interventional

The Budesonide in Babies (BiB) Trial

SponsorNICHD Neonatal Research NetworkEnrollment642Bronchopulmonary Dysplasia (BPD)NeonatalPrematurity; ExtremeRespiratory Distress Syndrome
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

  • Duke University

    Durham, North Carolina, United States

  • Rti International

    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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Budesonide →Surfactants
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Apr 2021
Primary completion
5 Sept 2024
Completion
17 Dec 2026
Last update posted
15 Apr 2026
Registered enrollment
642
Registry id
NCT04545866
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.