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

NCT00004669 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

DRUG

hydrocortisone

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Kristi L. Watterberg · Penn State University

Study Design

Purpose
PREVENTION

Eligibility

Min Age
0 Years
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004669 on ClinicalTrials.gov