Respiratory Distress Syndrome Clinical Trial
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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