To the Editor: We were disappointed that the
study of Dr Guinn and colleagues1 had to
be stopped early before reaching its intended sample size and thus lacks power
for finding smaller but clinically important reductions in adverse perinatal
outcomes. In this study only 502 women were randomized. We are coordinating
a study of similar design in Toronto, Ontario, in which women receive repeated
courses of antenatal corticosteroids or placebo every 14 days (projected n
= 1900). In the United Kingdom a similar study is under way in which antenatal
corticosteroids are given every 7 to 14 days. The primary outcomes of this
trial are death within the first year of life and mental impairment at 2 years
of age. Four thousand neonates will be enrolled to answer this question. Hopefully
such studies will provide the additional necessary power to determine if there
is important clinical benefit of weekly corticosteroids and to rule out the
possibility of harm.
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