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Early Cortisol Replacement for BPD Prevention
NCT00004669Phase 2
Key facts
- Status
- Completed
- Start
- Jun 1996
- Sponsor
- National Center for Research Resources
- Modality
- Small Molecules
- Drugs
- hydrocortisone
- Conditions
- bronchopulmonary dysplasia (BPD)
01
Overview
Phase 2, randomised, double-blind trial in bronchopulmonary dysplasia (BPD) comparing Hydrocortisone with Placebo (2 arms). Primary endpoint: Efficacy of cortisol replacement therapy for prevention of bronchopulmonary dysplasia at 12 days. Started Jun 1996; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hydrocortisone
Hydrocortisone IV every 12 hours for 12 days
Placebo
Placebo IV every 12 hours for 12 days
03
Who it enrols
Newborns with birth weight 500-999g, intubated at 12 hours of age, and able to receive treatment before 48 hours of life. Excludes infants with congenital sepsis, structural defects (liver, kidney, heart, lung), major congenital anomalies, or diabetic mothers.
04
Endpoints
Primary
Efficacy of cortisol replacement therapy for prevention of bronchopulmonary dysplasia
Secondary
Effect of cortisol replacement therapy on the signs of acute adrenal insufficiency
Adrenal hormone concentrations
Adrenal gland response to ACTH
Markers of inflammation in lung lavage fluid and peripheral blood leukocytes
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