Status:
COMPLETED
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Bronchopulmonary Dysplasia
Encephalomalacia
Eligibility:
All Genders
1-3 years
Phase:
PHASE2
Brief 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 out...
Detailed Description
Hypothesis: Among extremely low birth weight infants (ELBW; BW ≤ 1000 g) at high risk for bronchopulmonary dysplasia (BPD) and neurologic impairments, those infants randomized to seven days of hydroco...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00167544
Start Date
November 1 2005
End Date
November 1 2012
Last Update
August 30 2013
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 432025