Early Hydrocortisone Therapy for Bronchopulmonary Dysplasia Prevention
This study aims to evaluate the effectiveness of early hydrocortisone therapy in preventing bronchopulmonary dysplasia in newborns.
hydrocortisone
Infant, Premature, Diseases+9
+ Lung Diseases
+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Prevention Study
Summary
Study start date: June 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 1 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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