Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or...
Brief Summary
OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery.
II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease.
III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial Description
PROTOCOL OUTLINE: This is a randomized, double-blind study. Participants are stratified by participating institution.
Participants are randomly assigned to 1 of 2 treatment groups. The first group is treated with intravenous thyrotropin-releasing hormone (TRH) and intramuscular injections of betamethasone or dexamethasone. The second group receives a placebo in place of TRH.
Postnatal therapy with surfactants, prophylactic steroids, and indomethacin is allowed.
Intervention(s) in this Clinical Trial
- Drug: betamethasone
- Drug: dexamethasone
- Drug: thyrotropin-releasing hormone
Criteria for Participation in this Clinical Trial
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics-- Threatened premature delivery at 24 to 30 weeks gestation, i.e.: Premature labor Premature rupture of membranes Elective premature delivery medically indicated Fetal lung maturity immature or unknown --Prior/Concurrent Therapy-- No more than 72 hours since any initial corticosteroids --Patient Characteristics-- The following complications exclude: Fetal distress Amnionitis Severe maternal bleeding uncontrolled with transfusion or volume replacement Fetal or maternal heart disease Significant fetal blood loss Maternal blood pressure 140/90 mm Hg or higher with or without treatment
- Maternal hyperthyroidism Maternal hyperprolactinemic condition Significant fetal anomaly
- Multiple gestation with demise of 1 or more fetuses Nonimmune hydrops No participation in other clinical research projects
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Center for Research Resources (NCRR) NIH
Overall Clinical Trial Officials and Contacts
Roberta A. Ballard Study Chair Children's Hospital of Philadelphia
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004778
Study ID Number: 199/11826
ClinicalTrials.gov Identifier: NCT00004778
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00004778
