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 on February 24, 2000. Last Updated on 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 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

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

Infant, Newborn, Diseases
Hormones
Thyrotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012