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 Information
Recruitment Status
Drug
Estimated Enrollment
1160
Start Date
March 1, 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
Administrative Informations
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
February 2021