Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchopulmonary Dysplasia
Intervention: hydrocortisone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Kristi L. Watterberg, Study Chair, Affiliation: Penn State University
Summary
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.
Clinical Details
Study design: Prevention
Detailed description:
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
Minimum age: N/A.
Maximum age: 1 Year.
Gender(s): 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
Locations and Contacts
Additional Information
Starting date: June 1996
Last updated: June 23, 2005
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