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|
|Respiratory Distress Syndrome||Drug: thyrotropin-releasing hormone|
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)|
|Estimated Enrollment :||996 participants|
|Study Start Date :||May 1998|
|Estimated Study Completion Date :||June 1998|
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
|Study Chair:||Roberta A. Ballard||Children's Hospital of Philadelphia|