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NCT01353313 · ClinicalTrials.gov registry record · Phase 3
Hydrocortisone for BPD
A Phase 3 study of Bronchopulmonary Dysplasia and Infant, Newborn, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
- 20
- Study locations
NCT01353313 is a Phase 3 study of Bronchopulmonary Dysplasia and Infant, Newborn 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.
The verdict
NCT01353313, a Phase 3 study of Bronchopulmonary Dysplasia and Infant, Newborn, 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01353313
The ClinicalTrials.gov registry entry for NCT01353313 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 209-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (283% higher). The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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, Newborn, Infant, Premature, 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.
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