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Hydrocortisone for BPD
NCT01353313 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 44 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01353313 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Ohio, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01353313?
The interventions under investigation include: Placebo (DRUG), Hydrocortisone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01353313?
This trial is sponsored by NICHD Neonatal Research Network, which has 44 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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