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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)996 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

996

Conditions

Respiratory Distress Syndrome

Interventions

thyrotropin-releasing hormoneDRUG

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 36 Years

Medical Language ↔ Plain English

* 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

Data from ClinicalTrials.gov

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