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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	Children's Hospital of Philadelphia
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004840

Purpose

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.

Condition	Intervention
Respiratory Distress Syndrome	Drug: thyrotropin-releasing hormone

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Protirelin Thyrotropin

U.S. FDA Resources

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

Estimated Enrollment:	996
Study Start Date:	May 1998
Estimated Study Completion Date:	June 1998

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years to 36 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004840

Sponsors and Collaborators

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

Children's Hospital of Philadelphia

Investigators

Study Chair:

Roberta A. Ballard

Children's Hospital of Philadelphia

More Information

No publications provided

Study ID Numbers:	199/13784, CHP-5R01HD29201-03
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004840 History of Changes
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 Tract Diseases
Lung Diseases
Physiological Effects of Drugs
Respiration Disorders
Respiratory Distress Syndrome, Adult

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Thyrotropin-Releasing Hormone

ClinicalTrials.gov processed this record on March 18, 2010