Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT00004840|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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 or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome||Drug: thyrotropin-releasing hormone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||996 participants|
|Study Start Date :||May 1998|
|Study Completion Date :||June 1998|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004840
|Study Chair:||Roberta A. Ballard||Children's Hospital of Philadelphia|