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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Children's Hospital of Philadelphia |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004778 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Distress Syndrome |
Drug: betamethasone Drug: dexamethasone Drug: thyrotropin-releasing hormone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Estimated Enrollment: | 1090 |
| Study Start Date: | August 1993 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
| Study ID Numbers: | 199/11826, CHP-92536 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004778 History of Changes |
| Health Authority: | United States: Federal Government |
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cardiovascular and respiratory diseases neonatal disorders rare disease respiratory distress syndrome |
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Anti-Inflammatory Agents Betamethasone-17,21-dipropionate Dexamethasone Antineoplastic Agents, Hormonal Hormone Antagonists Betamethasone sodium phosphate Respiration Disorders Respiratory Distress Syndrome, Adult Hormones, Hormone Substitutes, and Hormone Antagonists Rare Diseases Acute Respiratory Distress Syndrome Antiemetics |
Anti-Asthmatic Agents Glucocorticoids Hormones Thyrotropin-Releasing Hormone Respiratory Tract Diseases Lung Diseases Infant, Newborn, Diseases Peripheral Nervous System Agents Betamethasone Dexamethasone acetate Premature Birth |
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Anti-Inflammatory Agents Dexamethasone Respiratory System Agents Antineoplastic Agents Respiratory Distress Syndrome, Adult Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Thyrotropin-Releasing Hormone Pathologic Processes Respiratory Tract Diseases Therapeutic Uses |
Syndrome Betamethasone Disease Antineoplastic Agents, Hormonal Respiration Disorders Gastrointestinal Agents Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Peripheral Nervous System Agents Central Nervous System Agents |
