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

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.

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Drug: hydrocortisone

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.

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention

Collaborators and Investigators

• Sponsor: National Center for Research Resources (NCRR)
• Collaborators: Penn State University
• Investigators: Study Chair: Kristi L. Watterberg, Penn State University

Study record dates

Study Major Dates

• Study Start: June 1, 1996

Study Registration Dates

• First Submitted: February 24, 2000
• First Submitted That Met QC Criteria: February 24, 2000
• First Posted (Estimate): February 25, 2000

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: December 1, 2001

More Information

Terms related to this study

• Keywords: rare disease; bronchopulmonary dysplasia; cardiovascular and respiratory diseases; neonatal disorders
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: 199/12016; PENN-420633