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

Primary Purpose

Bronchopulmonary Dysplasia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
hydrocortisone
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring bronchopulmonary dysplasia, cardiovascular and respiratory diseases, neonatal disorders, rare disease

Eligibility Criteria

0 Years - 1 Year (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004669
    Brief Title
    Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Penn State University

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchopulmonary Dysplasia
    Keywords
    bronchopulmonary dysplasia, cardiovascular and respiratory diseases, neonatal disorders, rare disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    hydrocortisone

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristi L. Watterberg
    Organizational Affiliation
    Penn State University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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