NCT00004778

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,090 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: Female
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	betamethasone
DRUG	dexamethasone
DRUG	thyrotropin-releasing hormone

Timeline

• Start date: 1993-08-01
• First posted: 2000-02-25
• Last updated: 2005-06-24