Hydrocortisone for BPD
Completed · Phase 3 · Has a placebo group
Conditions studied: Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature, Bronchopulmonary Dysplasia
In brief
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.
Key facts
- Study ID
- NCT01353313
- Run by
- NICHD Neonatal Research Network
- People needed
- 800
- Starts
- 2011-08-11
- Expected to finish
- 2024-09-12
- Last updated by the study team
- 2025-02-27
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- infants <30 weeks estimated gestational age
- inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age
- have received at least 7days of mechanical ventilation;
- are receiving mechanical ventilation through an endotracheal tube .
You may not qualify if…
- Major congenital anomalies
- Decision to limit support
- Indomethacin or ibuprofen treatment within 48 hours of study drug
- Previous corticosteroid treatment for BPD
- Received hydrocortisone for 14 or more cumulative days
- Received hydrocortisone within 7 days of study entry
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- University of California - Los Angeles — Los Angeles, California, United States
- Stanford University — Palo Alto, California, United States
- Emory University — Atlanta, Georgia, United States
- Indiana University — Indianapolis, Indiana, United States
- University of Iowa — Iowa City, Iowa, United States
- Wayne State University — Detroit, Michigan, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
- University of New Mexico — Albuquerque, New Mexico, United States
- University of Rochester — Rochester, New York, United States
- RTI International — Durham, North Carolina, United States
- Duke University — Durham, North Carolina, 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
- Univeristy of Pennsylvania — Philadelphia, Pennsylvania, United States
- Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
- University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
- University of Texas Health Science Center at Houston — Houston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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