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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:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004840
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: October 1998

February 24, 2000
June 23, 2005
May 1998
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Complete list of historical versions of study NCT00004840 on ClinicalTrials.gov Archive Site
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Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
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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.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Respiratory Distress Syndrome
Drug: thyrotropin-releasing hormone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
996
June 1998
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  • 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
Female
20 Years to 36 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004840
199/13784, CHP-5R01HD29201-03
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital of Philadelphia
Study Chair: Roberta A. Ballard Children's Hospital of Philadelphia
Office of Rare Diseases (ORD)
October 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP