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NCT01353313 · ClinicalTrials.gov registry record · Phase 3
Hydrocortisone for BPD
A Phase 3 study of Bronchopulmonary Dysplasia and Infant, Premature, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
- 20
- Study locations
NCT01353313: Completed Phase 3 study of Bronchopulmonary Dysplasia and Infant, Premature, sponsored by NICHD Neonatal Research Network.
NCT01353313 is a Phase 3 study of Bronchopulmonary Dysplasia and Infant, Premature that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 800 participants, above the 209-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (283% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01353313, a Phase 3 study of Bronchopulmonary Dysplasia and Infant, Premature, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.
Primary Outcome
Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydrocortisone
Study Locations (20)
Ohio
- Cincinnati Children's Medical Center - Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital - Cleveland
- Research Institute at Nationwide Children's Hospital - Columbus
California
- University of California - Los Angeles - Los Angeles
- Stanford University - Palo Alto
North Carolina
- RTI International - Durham
- Duke University - Durham
Texas
- University of Texas Southwestern Medical Center at Dallas - Dallas
- University of Texas Health Science Center at Houston - Houston
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Emory University - Atlanta
Indiana
- Indiana University - Indianapolis
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2011-08-11 |
| Est. Completion | 2024-09-12 |
| Phase | Phase 3 |
What the finished NCT01353313 record still lists
NCT01353313 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 209-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (283% higher).
The record links to 5 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01353313 names 20 study sites across 15 states, led by Ohio, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01353313 about?
NCT01353313 is a clinical study titled "Hydrocortisone for BPD". The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study wil...
What is the current status of trial NCT01353313?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2011-08-11. Estimated completion is 2024-09-12.
What conditions does trial NCT01353313 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Infant, Premature, Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight.
What interventions are being tested in trial NCT01353313?
The interventions under investigation include: Placebo (DRUG), Hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT01353313?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01353313 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bronchopulmonary Dysplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01353313's enrollment target sits among peer trials
800 1st of 29 higher than 29 of 29 other Bronchopulmonary Dysplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bronchopulmonary Dysplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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