Management of Patent Ductus in Premature Infants
Information source: National Heart, Lung, and Blood Institute (NHLBI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases; Defect, Congenital Heart; Ductus Arteriosus, Patent; Heart Diseases
Intervention: indomethacin (Drug); surgery, cardiovascular (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s):
Alexander Nadas, Affiliation: Children's Hospital Medical Center
Summary
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: 1 Year.
Gender(s): Both.
Criteria:
Boy and girl premature infants with patent ductus arteriosus. Birth weight of 1,750 grams
or less. Admitted to participating institution within first 24 hours of life.
Locations and Contacts
Additional Information
Related publications: Gersony WM, Peckham GJ, Ellison RC, Miettinen OS, Nadas AS. Effects of indomethacin in premature infants with patent ductus arteriosus: results of a national collaborative study. J Pediatr. 1983 Jun;102(6):895-906. Ellison RC, Peckham GJ, Lang P, Talner NS, Lerer TJ, Lin L, Dooley KJ, Nadas AS. Evaluation of the preterm infant for patent ductus arteriosus. Pediatrics. 1983 Mar;71(3):364-72.
Starting date: September 1978
Last updated: June 23, 2005
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