At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
Hydrocortisone +1 moredrug
Likely dose
Hydrocortisone 3 mg/kg/day divided every 12 hours IV/PO, tapered over 7 daysAI-extracted
Key inclusion· 4
- ✓Birth weight ≤1000 grams
- ✓Enrolled in MHCH neonatal ICU
- ✓Ventilator-dependent between 10 and 21 days of age
- ✓Respiratory index score ≥2.0 (increasing or stable) or ≥3.0 (with improvement) over past 24 hours
Key exclusion· 5
- ✕Prior postnatal steroid treatment
- ✕Evidence of sepsis or necrotizing enterocolitis
- ✕Known major congenital anomalies of the cardiopulmonary or central nervous system
- ✕Current indomethacin treatment or anticipated use within next 7 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments
In Brief
A Phase 2 clinical trial evaluating Hydrocortisone and Placebo for Bronchopulmonary Dysplasia and 2 related conditions. Completed, enrolled 64 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2005
Enrollment StartNov 2005
Primary CompletionJan 2009
Study CompletionNov 2012
TodayJul 2026
First PostedSep 14, 2005
Enrollment StartNov 1, 2005
Primary CompletionJan 1, 2009
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.8 years ago
Interventions
Hydrocortisonedrug
Hydrocortisone 3 mg/kg/d divided q 12h IV/PO tapered over 7 days
Placebodrug
Saline