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

This study has been completed.
Sponsor:
Collaborator:
Penn State University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004669
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001

February 24, 2000
June 23, 2005
June 1996
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Complete list of historical versions of study NCT00004669 on ClinicalTrials.gov Archive Site
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Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia
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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.

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.

Interventional
Phase 2
Primary Purpose: Prevention
Bronchopulmonary Dysplasia
Drug: hydrocortisone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004669
199/12016, PENN-420633
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National Center for Research Resources (NCRR)
Penn State University
Study Chair: Kristi L. Watterberg Penn State University
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP