Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Respiratory Distress Syndrome

Treatments: Drug: thyrotropin-releasing hormone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004840

CHP-5R01HD29201-03

199/13784

Details and patient eligibility

About

OBJECTIVES:

I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing hormone to women in premature labor to improve pulmonary outcomes in preterm infants.

Full description

PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to receive antenatal thyrotropin-releasing hormone or placebo.

Patients receive thyrotropin-releasing hormone or placebo intravenously over 20 minutes every 8 hours for 4 doses.

Infants are assessed for survival and chronic lung disease until day 28 after birth, and again at 36 postmenstrual weeks.

Sex: Female

Ages: 20 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Pregnant women in active labor with 24-29 weeks gestation
• Not eligible if any of the following is present: Bleeding Infection Hypertension (greater than 140/90 mmHg) Fetus with hydrops or life-threatening anomalies One dead fetus in multiple pregnancy