Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004778
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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

Estimated Enrollment: 1090
Study Start Date: August 1993
Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004778

Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Study Chair: Roberta A. Ballard Children's Hospital of Philadelphia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004778     History of Changes
Other Study ID Numbers: 199/11826, CHP-92536
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
cardiovascular and respiratory diseases
neonatal disorders
rare disease
respiratory distress syndrome

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Betamethasone-17,21-dipropionate
Dexamethasone acetate
Betamethasone
Dexamethasone
Betamethasone sodium phosphate
Dexamethasone 21-phosphate
Hormones
Thyrotropin-Releasing Hormone
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on April 17, 2014