NCT00004669

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Bronchopulmonary Dysplasia

Keywords

bronchopulmonary dysplasiacardiovascular and respiratory diseasesneonatal disordersrare disease

Interventions

hydrocortisoneDRUG

Eligibility Criteria

Age0 Years - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchopulmonary DysplasiaRespiratory Tract DiseasesInfant, Newborn, DiseasesRare Diseases

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesInfant, Premature, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Kristi L. Watterberg

    Penn State University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

June 1, 1996

Last Updated

June 24, 2005

Record last verified: 2001-12