The Budesonide in Babies (BiB) Trial

Phase 3

Active, not recruiting

• Conditions: Bronchopulmonary Dysplasia (BPD); Respiratory Distress Syndrome; Prematurity; Extreme; Neonatal

• Registration Number: NCT04545866
• Lead Sponsor: NICHD Neonatal Research Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-9-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1160

Inclusion Criteria

Inclusion Criteria:<br><br> - Liveborn infants 22 0/7 - 28 6/7 weeks gestation or 401 - 1000 grams (inclusive)<br> birth weight<br><br> - Clinical decision to give surfactant<br><br> - Less than or equal to 48 hours postnatal age<br><br>Exclusion Criteria:<br><br> - Terminal illness (heart rate < 100 beats per minute, unresponsiveness to<br> resuscitation) or unlikely to survive as judged by the clinician<br><br> - Decision to redirect or limit support<br><br> - Use of surfactant before enrollment (first dose of surfactant must be study drug)<br><br> - Infant received systemic steroids prior to enrollment<br><br> - Use of indomethacin, either received by the mother within 24 hours prior to<br> delivery,received by the infant prior to enrollment, or intent to administer to the<br> infant for IVH prophylaxis or PDA management from enrollment up to 7 days of final<br> dose of study drug<br><br> - Serious chromosomal abnormalities or major malformations<br><br> - Known congenital infections including, but not limited to, confirmed sepsis,<br> congenital CMV, etc.<br><br> - Infants with a permanent neuromuscular condition that affects respiration<br><br> - Enrollment in a conflicting clinical trial

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Physiologic BPD or death

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Death by 36 weeks' post-menstrual age;Number of Participants with Physiologic BPD;Grade of BPD Severity;Number of Participants with Grade 3 BPD;Number of Participants with Use of Additional Postnatal Steroids;Number of Participants with Severe Neurodevelopmental Impairment (NDI);Number of Participants with Death by 2 years;Number of Participants with Severe NDI or death