Short Versus Prolonged Indomethacin Therapy for Patent Ductus Arteriosus in Preterm Infants

J Pediatr. 1999 May;134(5):552-7. doi: 10.1016/s0022-3476(99)70239-8.

Abstract

Objective: To evaluate whether a prolonged low-dose course of indomethacin would produce an improved closure rate and have fewer side effects compared with a short standard dosage schedule in the management of patent ductus arteriosus (PDA) in preterm infants.

Study design: Sixty-one infants of gestational ages 24 to 32 weeks with a PDA confirmed with echocardiography were randomized to receive 0.2 to 0.1 to 0.1 mg/kg indomethacin in 24 hours (short course, n = 31) or 0.1 mg/kg every 24 hours 7 times (long course, n = 30). Echocardiography was done 3, 9, and 14 days after the treatment was started, and side effects were monitored.

Results: Primary PDA closure occurred more often in the short course group (94% vs 67%, P =.011), but the sustained closure rates were not different (74% vs 60%). Surgical PDA ligations were less frequent in the short course group than in the long course group. The short course group had a shorter duration of oxygen supplementation, less frequent symptoms of necrotizing enterocolitis, and a lower rate of urea retention. Mortality and other neonatal morbidity rates were similar.

Conclusion: A prolonged low-dosage indomethacin regimen offers no advantage compared with a standard-dosage short course in the management of a hemodynamically significant PDA in preterm infants.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Cyclooxygenase Inhibitors / administration & dosage*
  • Cyclooxygenase Inhibitors / therapeutic use
  • Ductus Arteriosus, Patent / diagnosis
  • Ductus Arteriosus, Patent / drug therapy*
  • Echocardiography
  • Gestational Age
  • Humans
  • Indomethacin / administration & dosage*
  • Indomethacin / therapeutic use
  • Infant, Newborn
  • Infant, Premature
  • Infant, Premature, Diseases / drug therapy*
  • Treatment Outcome

Substances

  • Cyclooxygenase Inhibitors
  • Indomethacin