Budesonide + Surfactant for Premature Birth Complications

(BiB Trial)

Recruiting at18 trial locations

Overseen by Namasivayam Ambalavanan, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NICHD Neonatal Research Network

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a mix of a steroid and a lung-helping substance on very premature babies to reduce severe lung problems or death. The treatment works by reducing lung inflammation and helping the lungs stay open. Steroids like dexamethasone have been used to treat and prevent chronic lung disease in infants, showing beneficial effects.

Research Team

Namasivayam Ambalavanan, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

I am approved to receive surfactant therapy.

My baby is 48 hours old or younger.

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

Exclusion Criteria

My baby or I have used, or plan to use, indomethacin for IVH prevention or PDA treatment.

Enrollment in a conflicting clinical trial

You have certain infections that you were born with, such as confirmed sepsis or congenital CMV.

Treatment Details

Interventions

• Budesonide (Corticosteroid)
• Surfactant (Other)

Trial Overview 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.

Participant Groups

Group I: budesonide with surfactant Experimental Treatment 1 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 alone Active Control 1 Intervention

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

Budesonide is already approved in Canada for the following indications:

Approved in Canada as Pulmicort for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Allergic rhinitis

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials

62

Recruited

209,000+

Dr. Diana W. Bianchi

NICHD Neonatal Research Network

Chief Executive Officer since 2016

MD from Tufts University School of Medicine

Dr. Krisa Van Meurs

NICHD Neonatal Research Network

Chief Medical Officer since 2023

MD from Stanford University School of Medicine

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland