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Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus.

Tim Hundscheid1, Wes Onland1, Elisabeth M W Kooi1

  • 1From the Department of Pediatrics, Division of Neonatology (T.H., W.P.B.), and the Department for Health Evidence (R.D.), Radboud University Medical Center, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, the Department of Neonatology, Amsterdam Reproduction and Development, Emma Children's Hospital, Amsterdam University Medical Centers (W.O., W.B.V., A.H.K., T.B.), and Neonatology Network Netherlands (D.H.G.M.N.), Amsterdam, University Medical Center Groningen, Beatrix Children's Hospital, and the Department of Pediatrics, Division of Neonatology, University of Groningen (E.M.W.K., P.H.D.), Groningen, the Division of Woman and Baby, Department of Neonatology, University Medical Center Utrecht, Utrecht University, Wilhelmina Children's Hospital, Utrecht (D.C.V., W.B.V.), the Department of Neonatology, Maxima Medical Center Veldhoven, Veldhoven (K.P.D.), Maastricht University Medical Center, the Department of Pediatrics, Division of Neonatology, School for Oncology and Reproduction, University of Maastricht, Maastricht (E.V.), the Department of Pediatrics, Division of Neonatology, Erasmus Medical Center Rotterdam, Sophia Children's Hospital, Rotterdam (A.A.K.), the Department of Pediatrics, Division of Neonatology, Leiden University Medical Center, Willem Alexander Children's Hospital, Leiden (R.V.), and the Department of Pediatrics, Division of Neonatology, Isala Women's and Children's Hospital Zwolle, Zwolle (S.M.M.-T.) - all in the Netherlands; the Department of Neonatology, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel (B.D.B.), the Department of Pediatrics, Division of Neonatology, Hôpital Universitaire des Enfants Reine Fabiola (D.A.), the Department of Pediatrics, Division of Neonatology, Cliniques Universitaires St. Luc (C.H.), the Department of Neonatology, Cliniques Universitaires de Bruxelles, Hôpital Erasme (F.D., B.V.O.), and Kind en Gezin-Opgroeien, Flemish Government, Sint-Gillis (B.V.O.), Brussels, the Department of Pediatrics, Division of Neonatology, Ghent University Hospital, Ghent (A.Z.), and the Department of Neonatology, Antwerp University Hospital, Edegem (A.L.M., M.M.) - all in Belgium; and the Departments of Pediatrics and Adolescent Medicine and Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark (T.B.H., K.J.K.).

The New England Journal of Medicine
|December 8, 2022
PubMed
Summary

For extremely preterm infants, watchful waiting for patent ductus arteriosus (PDA) showed similar outcomes to early ibuprofen treatment, reducing the need for medication.

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Area of Science:

  • Neonatal Medicine
  • Pediatric Cardiology
  • Clinical Trials

Background:

  • Patent ductus arteriosus (PDA) is common in extremely preterm infants.
  • Cyclooxygenase inhibitors are frequently used, but their efficacy is uncertain.

Purpose of the Study:

  • To compare expectant management with early ibuprofen for PDA in extremely preterm infants.
  • To determine if expectant management is noninferior to early ibuprofen.

Main Methods:

  • Multicenter noninferiority trial involving 273 extremely preterm infants (<28 weeks' gestational age) with confirmed PDA.
  • Infants were randomized to expectant management or early ibuprofen treatment.
  • Primary outcome: composite of necrotizing enterocolitis, bronchopulmonary dysplasia, or death at 36 weeks' postmenstrual age.

Main Results:

  • Expectant management was noninferior to early ibuprofen. Primary outcome events occurred in 46.3% (expectant) vs. 63.5% (ibuprofen) (absolute risk difference: -17.2%).
  • Rates of necrotizing enterocolitis were similar (17.6% vs. 15.3%).
  • Bronchopulmonary dysplasia rates were lower in the expectant group (33.3% vs. 50.9%).

Conclusions:

  • Expectant management is a viable alternative to early ibuprofen for PDA in extremely preterm infants.
  • This approach demonstrated noninferiority regarding the composite outcome of major morbidities or death.