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Corticosteroid

Budesonide + Surfactant for Premature Birth Complications (BiB Trial)

Phase 3

Recruiting

Led By Namasivayam Ambalavanan, MD

Research Sponsored by NICHD Neonatal Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Liveborn infants 22 0/7 - 28 6/7 weeks gestation or 401 - 1000 grams (inclusive) birth weight

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 22-26 months corrected age

Awards & highlights

BiB Trial Summary

This trial is testing whether adding budesonide to surfactant given early to extremely premature infants will reduce the incidence of BPD or death by 36 weeks PMA.

Who is the study for?

The BiB Trial is for liveborn infants born between 22 and 28 weeks of gestation or weighing between 401 - 1000 grams. They must be less than 48 hours old and require surfactant treatment. Infants with certain conditions, previous steroid use, enrollment in another trial, or major malformations are not eligible.Check my eligibility

What is being tested?

This study tests if giving budesonide combined with surfactant directly into the windpipe reduces death or bronchopulmonary dysplasia (a lung condition) in extremely premature babies by the time they reach a corrected age of about nine months.See study design

What are the potential side effects?

Potential side effects may include immune system suppression, growth delays, adrenal gland problems, thrush in the mouth and throat area from budesonide; surfactant can cause blockage of airways, changes in blood pressure, and infections.

BiB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby was born between 22 and 28 weeks of pregnancy or weighed between 401 and 1000 grams at birth.

BiB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22-26 months corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~22-26 months corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 22-26 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Physiologic BPD or death

Secondary outcome measures

Grade of BPD Severity

Number of Participants with Death by 2 years

Number of Participants with Death by 36 weeks' post-menstrual age

+5 more

BiB Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: budesonide with surfactantExperimental Treatment1 Intervention

Infants randomized to the intervention arm receive a dose of surfactant (poractant alfa; Curosurf) mixed with budesonide (Pulmicort nebulizing suspension) within 50 hours of birth and administered via endotracheal tube.

Group II: surfactant aloneActive Control1 Intervention

Infants randomized to the active control arm receive a dose of surfactant (poractant alfa; Curosurf).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NICHD Neonatal Research NetworkLead Sponsor

59 Previous Clinical Trials

204,610 Total Patients Enrolled

15 Trials studying Premature Birth

16,826 Patients Enrolled for Premature Birth

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,673,490 Total Patients Enrolled

66 Trials studying Premature Birth

119,510 Patients Enrolled for Premature Birth

Namasivayam Ambalavanan, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

6 Previous Clinical Trials

1,310 Total Patients Enrolled

3 Trials studying Premature Birth

197 Patients Enrolled for Premature Birth

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04545866 — Phase 3

Premature Birth Research Study Groups: budesonide with surfactant, surfactant alone

Premature Birth Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT04545866 — Phase 3

Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04545866 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is budesonide (Pulmicort nebulizing suspension) most commonly taken?

"Budesonide, trade-named Pulmicort nebulizing suspension, is an effective medical treatment for iga glomerulonephritis, rhino sinusitis, and eosinophilic esophagitis (eoe)."

Answered by AI

Are people still being signed up for this experiment?

"That is correct. According to the clinicaltrials.gov listing, this trial is still open and recruiting patients. This particular study was first posted on March 15th, 2021 and was last updated on April 4th, 2022. They are looking for a total of 1160 patients from 15 different sites."

Answered by AI

Is budesonide (Pulmicort nebulizing suspension) a new medication?

"Currently, there are 35 ongoing clinical trials studying budesonide (Pulmicort nebulizing suspension). Out of those, 10 have reached Phase 3. The majority of these medical studies are based in Xi'an, Shaanxi, but there are 994 locations worldwide conducting research on this medication."

Answered by AI

What is the FDA's opinion on budesonide?

"There is some evidence demonstrating budesonide's efficacy and it has undergone multiple rounds of safety testing, so it received a score of 3."

Answered by AI

Are there other research facilities also testing this in Canada?

"Enrollment for this study is presently ongoing at 15 sites, which are primarily situated in larger cities such as Philadelphia, Palo Alto and Birmingham. To reduce the amount of travel required, patients are encouraged to enroll at the location closest to them."

Answered by AI

How many people are being included in this research project?

"In order to carry out this study, 1160 willing and eligible patients are required. These individuals can participate at either the University of Pennsylvania in Philadelphia or Stanford University in Palo Alto."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Budesonide in Babies (BiB) Trial

2021. "The Budesonide in Babies (BiB) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04545866.

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