Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
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|ClinicalTrials.gov Identifier: NCT00004778|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery.
II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease.
III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome||Drug: betamethasone Drug: dexamethasone Drug: thyrotropin-releasing hormone||Phase 3|
PROTOCOL OUTLINE: This is a randomized, double-blind study. Participants are stratified by participating institution.
Participants are randomly assigned to 1 of 2 treatment groups. The first group is treated with intravenous thyrotropin-releasing hormone (TRH) and intramuscular injections of betamethasone or dexamethasone. The second group receives a placebo in place of TRH.
Postnatal therapy with surfactants, prophylactic steroids, and indomethacin is allowed.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1090 participants|
|Study Start Date :||August 1993|
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): NCT00004778
|Study Chair:||Roberta A. Ballard||Children's Hospital of Philadelphia|