Randomized Controlled Trial of Budesonide + Surfactant versus Surfactant Alone in Extremely Preterm Infants (“The Budesonide in Babies (BiB) Trial”)
Study ID: STU-2020-0878
The study looks to see the effects of early intratracheal administration of a combination of budesonide with surfactant (intervention) on the incidence of physiologic bronchopulmonary dysplasia (BPD) or death by 36 weeks' post-menstrual age in extremely preterm infants. The study hopes to reflect a reduction in the incidence of BPD in this patient population as compared to surfactant alone (active control). The study will be a randomized, masked, active-controlled multicenter clinical trial with 1:1 allocation to two treatment arms and will include liveborn infants 22 0/7 x 28 6/7 weeks gestation or 401 x 1000 grams (inclusive) birth weight with clinical decision to give surfactant. enrolled infants will receive budesonide + surfactant (intervention group) or surfactant alone (active control group) as soon as the clinical decision to give surfactant is made in the window of [Less Than] 48h postnatal age (study drug initiation can occur at [Less Than] 50 hours postnatal age). Based on a randomization schedule centrally generated by the nRn Data Coordinating Center (DCC) at RTi, drug kits of budesonide respules or sham will be randomized, assembled, masked, and labeled by the investigational Drug/Research Pharmacy at each site. The research pharmacy will receive a computer-generated code number from dispensed (opened) and returned drug kits that will be linked to each enrolled infant upon randomization. infants randomized to the active control arm will receive a dose of Curosurf (poractant alfa) while infants randomized to the intervention arm will receive a dose of Curosurf mixed with budesonide (Pulmicort nebulizing suspension). * Primary outcome: Physiologic BPD or death by 36 weeks post-menstrual age (PMa) * Secondary outcomes: Death by 36w PMa; Physiologic BPD at 36w PMa; BPD severity by the Jensen et al. (2019) definition at 36w PMa (no BPD/Grade 1/Grade 2/Grade 3); Grade 3 BPD at 36w PMa; use of postnatal steroids for chronic lung disease by 36w PMa; severe neurodevelopmental impairment (nDi) assessed at 22-26 months corrected age; death by 22-26 months corrected age assessment; severe nDi/death by 22-26 months corrected age. * exploratory outcomes: BPD severity (none/Mild/Moderate/Severe) at 36w PMa by the niCHD definition; number of days on invasive mechanical ventilation by postnatal day 28; number of days on invasive mechanical ventilation by 36w PMa; intubation after the treatment window and by postnatal day 28; intubation after the treatment window and by 36w PMa; administration of repeat surfactant doses after the treatment window; respiratory outcomes (recurrent wheezing and chronic coughing) by 22-26 months corrected age. * Safety outcomes: Within the first week following last study drug administration (hypertension, hyperglycemia, prolonged hypoxemia with bradycardia, endotracheal tube blockage, hypotension, pulmonary air leak, sepsis, intracranial hemorrhage); within 30 days following last study drug administration (spontaneous intestinal perforation, periventricular leukomalacia); impairment of growth parameters assessed at 36w PMa (weight, length, head circumference).
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- LUC P BRION
NATIONAL INSTITUTE OF HEALTH AND WELFARE
early intratracheal administration of a combination of budesonide with surfactant (intervention), as compared to surfactant alone (active control) will reduce the incidence of physiologic bronchopulmonary dysplasia (BPD) or death by 36 weeks' post-menstrual age in extremely preterm infants.