Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants

Completed · Phase 2 · Has a placebo group

Conditions studied: Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth

In brief

The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.

Key facts

Study ID

NCT00167544

Run by

Nationwide Children's Hospital

People needed

64

Starts

2005-11-01

Expected to finish

2012-11-01

Last updated by the study team

2013-08-30

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient in the Memorial Hermann Children's Hospital (MHCH) neonatal intensive care unit with a birth weight ≤ 1000 grams.
• Ventilator-dependent between 10 and 21 days of age.
• Respiratory index score (RIS: mean airway pressure x fraction of inspired oxygen) of ≥ 2.0 that is increasing or stable for the previous 24 hours or a RIS ≥ 3.0 if improvement noted in the past 24 hours.

You may not qualify if…

• Prior postnatal steroid treatment.
• Evidence of sepsis or necrotizing enterocolitis.
• Known major congenital anomalies of the cardiopulmonary or central nervous system.
• Infants being treated with indomethacin or those likely to require treatment in the next 7 days as judged by the treating physician.
• Inability or unwillingness of parent or legal guardian/representative to give written informed consent.
• Gestational age < 23 weeks.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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