Cardiovascular Diseases Clinical Trial
To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed.
BACKGROUND:
The incidence of patent ductus arteriosus is higher in premature infants than in full-term
infants and is highest in premature infants who have respiratory distress syndrome. It is
generally agreed that intervention in an asymptomatic infant with a small left-to-right
shunt is unnecessary, since the patent ductus almost invariably closes spontaneously and
thus does not require surgery. A few infants will demonstrate signs of a large shunt during
the course of respiratory distress syndrome. Many of these infants will improve with medical
management of congestive heart failure, but others require surgical closure. A third group
of babies with respiratory distress have severe progressive pulmonary disease requiring
ventilatory support. There was disagreement as to whether elimination of the patent ductus
in these infants resulted in decreased mortality. A variety of therapeutic approaches was
being used, and there was no convincing evidence of the superiority of one treatment over
another.
DESIGN NARRATIVE:
Trial A was a randomized, double-blind trial in which indomethacin plus usual medical
therapy was compared with a placebo plus medical therapy. Where this regimen was
unsuccessful, the code was broken, and infants who received indomethacin were treated
surgically. Infants who had received placebo in Trial A were entered, if there were no
contraindications to indomethacin, into Trial B. In Trial B, infants were randomized to
surgery or indomethacin therapy. Those in whom indomethacin treatment was unsuccessful were
treated surgically. The Recruitment and Intervention Phase began in April 1979. All patients
were enrolled by March 31, 1981, and followed for one year after enrollment.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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