Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia
OBJECTIVES: I. Estimate the efficacy of cortisol replacement therapy during the first 12 days of life for prevention of bronchopulmonary dysplasia.
II. Estimate the effect of cortisol replacement therapy on the signs of acute adrenal insufficiency.
III. Evaluate the effects of cortisol replacement therapy on adrenal hormone concentrations and on the ability of the adrenal gland to respond to ACTH.
IV. Determine the effect of this replacement therapy on markers of inflammation in lung lavage fluid and peripheral blood leukocytes.
|Study Design:||Primary Purpose: Prevention|
|Study Start Date:||June 1996|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Hydrocortisone therapy IV or placebo begins no later than 48 hours after birth and continues every 12 hours for 12 days. Hydrocortisone is given at 2-4 times the basal cortisol secretion rate.
Tracheal lavage on intubated babies is performed at start of study and on day 4 of life to assess concentrations of inflammatory markers.
If larger babies show appropriate response to ACTH by 15-17 days and the less mature babies show a decreased response, then a longer course of therapy is proposed for future studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004669
|Study Chair:||Kristi L. Watterberg||Penn State University|