A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 21 days
Healthy Volunteers: No
View:

• 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.

Locations
United States
Ohio
Nationwide Children's Hospital
Columbus
Time Frame
Start Date: November 2005
Completion Date: November 2012
Participants
Target number of participants: 64
Treatments
Experimental: 1
1. Tapering dose of hydrocortisone every 12 h over 7 day period
Placebo Comparator: 2
2. Identical-appearing saline placebo
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Nationwide Children's Hospital

This content was sourced from clinicaltrials.gov

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