The Budesonide in Babies (BiB) Trial

Brief Title

The Budesonide in Babies (BiB) Trial

Official Title

Randomized Controlled Trial of Budesonide + Surfactant Versus Surfactant Alone in Extremely Preterm Infants ("The Budesonide in Babies (BiB) Trial")

Brief 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.
    

Detailed Description

      From a study of 9575 extremely preterm (22-28 weeks gestational age and 401-1500g birth
      weight) infants born between 2003 and 2007 and enrolled in the Eunice Kennedy Shriver
      National Institute of Child Health and Human Development (NICHD) Neonatal Research Network
      (NRN), it is anticipated that 93% of extremely preterm infants will develop respiratory
      distress syndrome, 68% will develop bronchopulmonary dysplasia (BPD), 16% will develop severe
      intraventricular hemorrhage, and 36% will develop late-onset sepsis (PMID: 20732945).
      Furthermore, in 2014 20% of the infants enrolled in the NRN Generic Database (GDB) died (8%
      by less than 12 hours, 12% between 12 hours and 120 days, and 1% after 120 days) and 47% of
      infants who survived to 36 weeks' post-menstrual age (PMA) developed physiologic BPD (NRN GDB
      data). BPD is therefore one of the most common morbidities in extremely preterm infants.
      Death is a competing outcome for BPD, as infants who die before ascertainment of BPD at 36
      weeks' PMA cannot be diagnosed with BPD even though they may have been at the highest risk.
      As children get older, BPD has been shown to be associated with worse cognitive outcomes in
      school age and with abnormal pulmonary function in adolescence and adulthood (PMID: 14595077;
      15499947; 2247118).

      Recent randomized trials have indicated a lower incidence of BPD/death with the use of a
      combination of budesonide with surfactant (budesonide + surfactant) compared to surfactant
      alone when administered soon after birth. Therefore, after obtaining informed consent and
      confirming eligibility for the trial, infants are randomized in a 1:1 allocation ratio to
      either the budesonide + surfactant arm or the surfactant alone arm within 48 hours of birth.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Number of Participants with Physiologic BPD or death

Secondary Outcome

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

Condition

Bronchopulmonary Dysplasia (BPD)

Intervention

budesonide (Pulmicort nebulizing suspension).

Study Arms / Comparison Groups

 budesonide with surfactant

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

1160

Start Date

March 15, 2021

Completion Date

September 2025

Primary Completion Date

March 31, 2023

Eligibility Criteria

        Inclusion Criteria:

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

          -  Clinical decision to give surfactant

          -  Less than or equal to 48 hours postnatal age

        Exclusion Criteria:

          -  Terminal illness (heart rate < 100 beats per minute, unresponsiveness to
             resuscitation) or unlikely to survive as judged by the clinician

          -  Decision to redirect or limit support

          -  Use of surfactant before enrollment (first dose of surfactant must be study drug)

          -  Infant received systemic steroids prior to enrollment

          -  Use of indomethacin, either received by the mother within 24 hours prior to
             delivery,received by the infant prior to enrollment, or intent to administer to the
             infant for IVH prophylaxis or PDA management from enrollment up to 7 days of final
             dose of study drug

          -  Serious chromosomal abnormalities or major malformations

          -  Known congenital infections including, but not limited to, confirmed sepsis,
             congenital CMV, etc.

          -  Infants with a permanent neuromuscular condition that affects respiration

          -  Enrollment in a conflicting clinical trial
      

Gender

All

Ages

N/A - 48 Hours

Accepts Healthy Volunteers

No

Contacts

Namasivayam Ambalavanan, MD, (205) 934 4680, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04545866

Organization ID

NICHD-NRN-0064

Secondary IDs

UG1HD034216

Responsible Party

Sponsor

Study Sponsor

NICHD Neonatal Research Network

Collaborators

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

Study Sponsor

Namasivayam Ambalavanan, MD, Principal Investigator, University of Alabama at Birmingham

Verification Date

March 2021