Effects of indomethacin in premature infants with patent ductus arteriosus: Results of a national collaborative study*

https://doi.org/10.1016/S0022-3476(83)80022-5Get rights and content

Among 3559 newborn infants with birth weight <1750 gm, 421 developing a hemodynamicallysignificant patent ductus arteriosus were entered into a randomized trial to evaluate the role of indomethacin in the management of PDA. Indomethacin given concurrently with usual medical therapy at the time of diagnosis resulted in ductal closure in 79%, versus 35% with placebo (P<0.001). Indomethacin as backup to usual medical treatment resulted in similar closure rates. To assess overall effects through hospital discharge, three management strategies were compared. Although mortality did not differ significantly, infants given indomethacin only if usual therapy failed (strategy 2) had a lower incidence of bleeding than those to whom indomethacin was given with initial medical therapy (strategy 1) and lower rates of pneumothorax and retrolental fibroplasia than those to whom no indomethacin was administered, with surgery the only backup to medical therapy (strategy 3). Thus the administration of indomethacin only when medical treatment fails appears to be the preferable approach for the management of syptomatic PDA in premature infants.

References (40)

  • CifuentesRF et al.

    Indomethacin and renal function in premature infants with persistent patent ductus arteriosus

    J Pediatr

    (1979)
  • CottonRB et al.

    Randomized trial of early closure of symptomatic patent ductus arteriosus in small preterm infants

    J Pediatr

    (1978)
  • MerrittTA et al.

    Patent ductus arteriosus treated with ligation or indomethacin: A follow-up study

    J Pediatr

    (1979)
  • YehTF et al.

    Intravenous indomethacin therapy in premature infants with persistent ductus arteriosus: A double-blind controlled study

    J Pediatr

    (1981)
  • YaffeSJ et al.

    The disposition of indomethacin in preterm babies

    J Pediatr

    (1980)
  • MerrittTA et al.

    Early closure of the patent ductus arteriosus in very low birth weight infants: A controlled trial

    J Pediatr

    (1981)
  • ThaljiAA et al.

    Pharmacokinetics of intravenously administered indomethacin in premature infants

    J Pediatr

    (1980)
  • DanilowiczD et al.

    Delayed closure of the ductus arteriosus in premature infants

    Pediatrics

    (1966)
  • KrovetzLJ et al.

    Patent ductus, prematurity and pulmonary disease

    N Engl J Med

    (1972)
  • JonesRW et al.

    Persistent ductus arteriosus complicating the respiratory distress syndrome

    Arch Dis Child

    (1977)
  • Cited by (0)

    *

    National Collaborative Study on Patent Ductus Arteriosus inPremature Infants.

    Supported by Grant HL 23121 from the National Heart, Lungand Blood Institute.

    View full text