Trial · NCT04545866

The Budesonide in Babies (BiB) Trial

NCT04545866, Phase 3, Active not recruiting, NICHD Neonatal Research Network; results first posted 2025-11-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Budesonide in Babies (BiB) Trial. Trials, record NCT04545866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04545866

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Budesonide in Babies (BiB) Trial
NCT number: NCT04545866
Status: Active not recruiting
Phases: Phase 3
Enrollment: 642 participants, actual
Lead sponsor: NICHD Neonatal Research Network
Conditions: Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
Interventions: budesonide (Pulmicort nebulizing suspension)., surfactant (poractant alfa;Curosurf)
First posted: 2020-09-11
Last updated: 2026-04-15
Results first posted: 2025-11-10

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Physiologic BPD or Death by 36 Weeks PMA	Randomization to 36 weeks PMA	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' PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks' PMA.
Secondary	Death by 36 Weeks PMA	Randomization to 36 weeks PMA	Died (all-cause) after randomization and by 36 weeks PMA
Secondary	Physiologic BPD	At 36 weeks PMA	Diagnosed with physiologic BPD at 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' PMA are not assessed for BPD.
Secondary	Grade of BPD Severity	At 36 weeks PMA	BPD Severity Grade at 36 weeks PMA according to the Jensen et al. (2019; PMID: 30995069) definition, also known as pragmatic BPD. Infants are assess based on the mode of support at 36 weeks' postmenstrual age regardless of prior duration or current level of oxygen therapy.
Secondary	Severe BPD	At 36 weeks PMA	Diagnosed with Severe (Grade 3) BPD at 36 weeks PMA according to the Jensen et al. (2019; PMID: 30995069) definition. This outcome is a dichotomy of the pragmatic BPD severity grades (Grade 3 vs. Grade 2, 1, or 0).
Secondary	Use of Additional Postnatal Steroids	7 days post last dose of study drug through 36 weeks PMA	Use of any postnatal steroids for treatment of evolving chronic lung disease (separate from study drug) between 7 days after the final dose of study drug and 36 weeks PMA. Note: Infants were permitted up to two doses of study drug within 50 hours postnatal age, so this outcome spans 7-10 days postnatal age through 36 weeks postmenstrual age.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Physiologic BPD or Death by 36 Weeks PMA	Randomization to 36 weeks PMA	An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Death by 36 Weeks PMA	Randomization to 36 weeks PMA	An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Physiologic BPD	At 36 weeks PMA	An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Grade of BPD Severity	At 36 weeks PMA	An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Severe BPD	At 36 weeks PMA	An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Use of Additional Postnatal Steroids	7 days post last dose of study drug through 36 weeks PMA	An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Physiologic BPD or Death by 36 Weeks PMA	BUDE	No	101	Participants
Physiologic BPD or Death by 36 Weeks PMA	SURF	No	102	Participants
Physiologic BPD or Death by 36 Weeks PMA	BUDE	Unknown	2	Participants
Physiologic BPD or Death by 36 Weeks PMA	SURF	Unknown	0	Participants
Physiologic BPD or Death by 36 Weeks PMA	BUDE	Yes	220	Participants
Physiologic BPD or Death by 36 Weeks PMA	SURF	Yes	216	Participants
Death by 36 Weeks PMA	BUDE	No	272	Participants
Death by 36 Weeks PMA	SURF	No	276	Participants
Death by 36 Weeks PMA	BUDE	Unknown	2	Participants
Death by 36 Weeks PMA	SURF	Unknown	0	Participants

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Budesonide + Surfactant	323
Overall Study	STARTED	Surfactant Alone	318
Overall Study	COMPLETED	Budesonide + Surfactant	321
Overall Study	COMPLETED	Surfactant Alone	318
Overall Study	NOT COMPLETED	Budesonide + Surfactant	2
Overall Study	NOT COMPLETED	Surfactant Alone	0

Source ClinicalTrials.gov

Adverse events132

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Leukocytosis	Blood and lymphatic system disorders	BUDE	0	323	0
other	Leukocytosis	Blood and lymphatic system disorders	SURF	1	318	1
other	Thrombocytopenia	Blood and lymphatic system disorders	BUDE	1	323	1
other	Thrombocytopenia	Blood and lymphatic system disorders	SURF	0	318	0
other	Left ventricular dysfunction	Cardiac disorders	BUDE	1	323	1
other	Left ventricular dysfunction	Cardiac disorders	SURF	0	318	0
other	Newborn persistent pulmonary hypertension	Congenital, familial and genetic disorders	BUDE	0	323	0
other	Newborn persistent pulmonary hypertension	Congenital, familial and genetic disorders	SURF	1	318	1
other	Patent ductus arteriosus	Congenital, familial and genetic disorders	BUDE	0	323	0
other	Patent ductus arteriosus	Congenital, familial and genetic disorders	SURF	1	318	1

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BUDE	49	323
Total, all-cause mortality	SURF	42	318
Total, other adverse events	BUDE	232	323
Total, other adverse events	SURF	187	318
Total, serious adverse events	BUDE	63	323
Total, serious adverse events	SURF	55	318

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41026481	DERIVED

Source PubMed

Grants20

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U24HD095254	Neonatal Research Network Data Coordinating Center (DCC) 2023-2028	DAS, ABHIK	RESEARCH TRIANGLE INSTITUTE	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2018 to 2025	NIH RePORTER
UG1HD021364	NICHD Neonatal Research Network Clinical Center - Case Western Reserve University	HIBBS, ANNA MARIA	CASE WESTERN RESERVE UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD027851	NICHD Neonatal Research Network	PATEL, RAVI MANGAL	EMORY UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD027853	NICHD Neonatal Research Network -- Cincinnati Clinical Center	MERHAR, STEPHANIE L	CINCINNATI CHILDRENS HOSP MED CTR	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD027880	NICHD Neonatal Research Network - Stanford University	CHOCK, VALERIE	STANFORD UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD034216	NICHD Neonatal Research Network Clinical Center UAB	CARLO FONT, WALDEMAR A.	UNIVERSITY OF ALABAMA AT BIRMINGHAM	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD040492	North Carolina Clinical Center	COTTEN, CHARLES MICHAEL; LAUGHON, MATTHEW; MOORE, RYAN THOMAS	DUKE UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD040689	NICHD COPPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK	WYCKOFF, MYRA HELEN	UT SOUTHWESTERN MEDICAL CENTER	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD053089	Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal ResearchNetwork	FULLER, JANELL	UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD053109	NICHD Cooperative Multicenter Neonatal Research Network	COLAIZY, TARAH TRINITY	UNIVERSITY OF IOWA	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER

1 to 10 of 20

See all 20 grants

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
BUDE vs SURF: deaths from any cause	Trial comparisons
BUDE vs SURF: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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