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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004840
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
Office of Rare Diseases (ORD)
  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
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 36 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00004840     History of Changes
Other Study ID Numbers: 199/13784
CHP-5R01HD29201-03
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
Last Verified: October 1998

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
Calcitonin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents