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

Bronchopulmonary Dysplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004669
• Other study ID #: 199/12016
• Secondary ID: PENN-420633
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: June 1996

Study information

• Verified date: December 2001
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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 Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Drug:
• hydrocortisone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Penn State University