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NCT00004840 Clinical Trial

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

Respiratory Distress Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004840
Other study ID # 199/13784
Secondary ID CHP-5R01HD29201-
Status Completed
Phase N/A
First received February 24, 2000
Last updated June 23, 2005
Start date May 1998
Est. completion date June 1998

Study information
Verified date October 1998
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 996
Est. completion date June 1998
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 36 Years
Eligibility - 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• thyrotropin-releasing hormone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Children's Hospital of Philadelphia
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