Respiratory Distress Syndrome Clinical Trial
— BiBOfficial title:
Randomized Controlled Trial of Budesonide + Surfactant Versus Surfactant Alone in Extremely Preterm Infants ("The Budesonide in Babies (BiB) Trial")
Verified date | July 2023 |
Source | NICHD Neonatal Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1160 |
Est. completion date | September 30, 2027 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 48 Hours |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | Emory University | Atlanta | Georgia |
United States | University of Alabama | Birmingham | Alabama |
United States | Northwestern Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | Cincinnati Children's Medical Center | Cincinnati | Ohio |
United States | Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | Research Institute at Nationwide Children's Hospital | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Duke University | Durham | North Carolina |
United States | RTI International | Durham | North Carolina |
United States | University of Texas Health Science Center at Houston | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | University of Mississippi Medical Center - Children's of Mississippi | Jackson | Mississippi |
United States | Stanford University | Palo Alto | California |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Brown University - Women and Infants Hospital of Rhode Island | Providence | Rhode Island |
United States | University of Rochester | Rochester | New York |
United States | University of Utah | Salt Lake City | Utah |
United States | Sharp Mary Birch Hospital for Women & Newborns | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
NICHD Neonatal Research Network | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Physiologic BPD or death | Physiologic BPD or death by 36 weeks' PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. | Randomization to 36 weeks' post-menstrual age | |
Secondary | Number of Participants with Death by 36 weeks' post-menstrual age | Death by 36 weeks' PMA | Randomization to 36 weeks' post-menstrual age | |
Secondary | Number of Participants with Physiologic BPD | Physiologic BPD as determined by existing NRN GDB criteria at 36 weeks' PMA. | 36 weeks' post-menstrual age | |
Secondary | Grade of BPD Severity | BPD severity is defined as in Jensen et al. (2019; PMID: 30995069) at 36 weeks' PMA according to treatment with the following respiratory support:
No BPD: room air; Grade 1: nasal cannula at flow rates = 2 L/min; Grade 2: nasal cannula at flow rates > 2 L/min or noninvasive positive airway pressure; Grade 3: invasive mechanical ventilation. |
36 weeks' post-menstrual age | |
Secondary | Number of Participants with Grade 3 BPD | Grade 3 BPD at 36 weeks' PMA according to the Jensen et al. (2019 PMID: 30995069) definition. | 36 weeks' post-menstrual age | |
Secondary | Number of Participants with Use of Additional Postnatal Steroids | Use of postnatal steroids for treatment of evolving chronic lung disease (separate from study drug) from 7 days after the final dose of study drug through 36 weeks' PMA. | 7 days post final dose of study drug through 36 weeks' post-menstrual age | |
Secondary | Number of Participants with Severe Neurodevelopmental Impairment (NDI) | Severe NDI is assessed at the 2-year follow-up (22-26 months corrected age). In light of the upcoming transition to BSID IV, severe NDI assessment will be based on the agreed upon definition at the time of the first participant's follow-up assessment. An example of such a definition could be presence of any of the following:
Cognitive composite score on the BSID IV < 70, GMFCS level 3-5, Severe hearing impairment (no functional hearing despite amplification), or Bilateral severe visual impairment (bilateral blindness despite correction). |
22-26 months corrected age | |
Secondary | Number of Participants with Death by 2 years | Death by 2-year follow-up (22-26 months corrected age) | Randomization to 22-26 months corrected age | |
Secondary | Number of Participants with Severe NDI or death | Severe NDI or death as assessed at 2-year follow-up (22-26 months corrected age) | Randomization to 22-26 months corrected age |
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