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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Penn State University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004669

Purpose

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.

Condition	Intervention	Phase
Bronchopulmonary Dysplasia	Drug: hydrocortisone	Phase II

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	40
Study Start Date:	June 1996

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.

Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004669

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Penn State University

Investigators

Study Chair:

Kristi L. Watterberg

Penn State University

More Information

No publications provided

Study ID Numbers:	199/12016, PENN-420633
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004669 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

bronchopulmonary dysplasia
cardiovascular and respiratory diseases
neonatal disorders
rare disease

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bronchopulmonary Dysplasia
Hydrocortisone
Cortisol succinate
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Rare Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Hydrocortisone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Bronchopulmonary Dysplasia
Hydrocortisone
Cortisol succinate
Respiratory Tract Diseases
Therapeutic Uses

Lung Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Hydrocortisone acetate
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009