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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Penn State University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004669 |
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 | Intervention | Phase |
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Bronchopulmonary Dysplasia |
Drug: hydrocortisone |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention |
Estimated Enrollment: | 40 |
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.
Ages Eligible for Study: | up to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Patient Characteristics--
Study ID Numbers: | 199/12016, PENN-420633 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004669 History of Changes |
Health Authority: | United States: Federal Government |
bronchopulmonary dysplasia cardiovascular and respiratory diseases neonatal disorders rare disease |
Anti-Inflammatory Agents Bronchopulmonary Dysplasia Hydrocortisone Cortisol succinate Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Rare Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Hydrocortisone acetate |
Anti-Inflammatory Agents Bronchopulmonary Dysplasia Hydrocortisone Cortisol succinate Respiratory Tract Diseases Therapeutic Uses |
Lung Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Hydrocortisone acetate Pharmacologic Actions |