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Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia



Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia

For Condition: Bronchopulmonary Dysplasia
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Pennsylvania State University Hospital
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Prevention
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry 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
Total Enrollment: 40

Location and Contact Information:

Overall Study Official:
KristiWatterberg,  Study Chair,  Pennsylvania State University Hospital


Additional Information:
Study ID Numbers:  199/12016;  PENN-420633
Study Start Date: June 1996
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004669

Other Bronchopulmonary Dysplasia Studies:
1. Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents with Infants at Risk of Sudden Death

2. Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

3. Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia

4. Premature Birth and its Sequelae in Women

5. Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)

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