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Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen

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posted on 2024-02-12, 16:25 authored by Samir Gupta, Nimesh V Subhedar, Jennifer Bell, David Field, Ursula Bowler, Elizabeth Hutchison, Samantha Johnson, Wilf Kelsall, Justine Pepperell, Tracy Roberts, Sunil Sinha, Kayleigh Stanbury, Jonathan Wyllie, Pollyanna Hardy, Edmund Juszczak

BACKGROUND

The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known.


METHODS

We conducted a multicenter, randomized, double-blind, placebo-controlled trial evaluating early treatment (≤72 hours after birth) with ibuprofen for a large PDA (diameter of ≥1.5 mm with pulsatile flow) in extremely preterm infants (born between 23 weeks 0 days’ and 28 weeks 6 days’ gestation). The primary outcome was a composite of death or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks of postmenstrual age.


RESULTS

A total of 326 infants were assigned to receive ibuprofen and 327 to receive placebo; 324 and 322, respectively, had data available for outcome analyses. A primary-outcome event occurred in 220 of 318 infants (69.2%) in the ibuprofen group and 202 of 318 infants (63.5%) in the placebo group (adjusted risk ratio, 1.09; 95% confidence interval [CI], 0.98 to 1.20; P=0.10). A total of 44 of 323 infants (13.6%) in the ibuprofen group and 33 of 321 infants (10.3%) in the placebo group died (adjusted risk ratio, 1.32; 95% CI, 0.92 to 1.90). Among the infants who survived to 36 weeks of postmenstrual age, moderate or severe bronchopulmonary dysplasia occurred in 176 of 274 (64.2%) in the ibuprofen group and 169 of 285 (59.3%) in the placebo group (adjusted risk ratio, 1.09; 95% CI, 0.96 to 1.23). Two unforeseeable serious adverse events occurred that were possibly related to ibuprofen.


CONCLUSIONS

The risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age was not significantly lower among infants who received early treatment with ibuprofen than among those who received placebo. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Baby-OSCAR ISRCTN Registry number, ISRCTN84264977. opens in new tab.)

History

Author affiliation

Department of Health Sciences, University of Leicester

Version

  • AM (Accepted Manuscript)

Published in

New England Journal of Medicine

Volume

390

Pagination

314-325

Publisher

Massachusetts Medical Society

issn

1533-4406

Copyright date

2024

Available date

2024-02-12

Language

en

Deposited by

Professor Samantha Johnson

Deposit date

2024-02-02

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