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.

Condition	Treatment or Intervention	Phase
Bronchopulmonary Dysplasia	Drug: hydrocortisone	Phase II

Further Study Details: 

Expected Total Enrollment:  40

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.

Ages Eligible for Study:  up to  1 Year,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics--

• At risk for development of bronchopulmonary dysplasia

--Patient Characteristics--

• Hematopoietic: No congenital sepsis
• Hepatic: No structural defect of liver
• Renal: No agenesis or structural defect of a kidney
• Cardiovascular: No structural defect of the heart
• Metabolic: No diabetic mothers (e.g., preexisting insulin dependent, noninsulin dependent, and gestational diabetes)
• Pulmonary: No structural defect of the lung
• Other: Newborn birth weight must be 500 to 999 g and have endotracheal tubes in place at 12 hours of age Eligible if treatment can be given before 48 hours of postnatal life No major congenital anomaly causing significant defect in major organ system

Study chairs or principal investigators

Kristi L. Watterberg,  Study Chair,  Pennsylvania State University Hospital   

Study ID Numbers:  199/12016; PENN-420633
Record last reviewed:  December 2001
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004669
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08