Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH)
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.