Early Treatment Versus Expectative Management of PDA in Preterm Infants

Summary

Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age \<28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has been associated with serious complications. However, a common finding is that medical and/or surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity. This might be related to the fact that a substantial portion of preterm infants are treated unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any specific intervention. An expectative approach is gaining interest, although convincing evidence is still missing. The objective of this study is to investigate whether in preterm infants \<28 weeks' gestation with a PDA an expectative management is not inferior to early treatment with regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks.

Timeline

Start

2016-12-23

Primary completion

2022-03-15

Completion

2022-03-15

Publications

• Results Hundscheid T, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Dijkman KP, van Kaam AH, Villamor E, Kroon AA, Visser R, Mulder-de Tollenaer SM, De Bisschop B, Dijk PH, Avino D, Hocq C, Zecic A, Meeus M, de Baat T, Derriks F, Henriksen TB, Kyng KJ, Donders R, Nuytemans DHGM, Van Overmeire B, Mulder AL, de Boode WP; BeNeDuctus Trial Investigators. Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus. N Engl J Med. 2023 Mar 16;388(11):980-990. doi: 10.1056/NEJMoa2207418. Epub 2022 Dec 6.
• Hundscheid T, Donders R, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Nuytemans DHGM, van Overmeire B, Mulder AL, de Boode WP; BeNeDuctus trial study group. Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan. Trials. 2021 Sep 15;22(1):627. doi: 10.1186/s13063-021-05594-x.
• Hundscheid T, Onland W, van Overmeire B, Dijk P, van Kaam AHLC, Dijkman KP, Kooi EMW, Villamor E, Kroon AA, Visser R, Vijlbrief DC, de Tollenaer SM, Cools F, van Laere D, Johansson AB, Hocq C, Zecic A, Adang E, Donders R, de Vries W, van Heijst AFJ, de Boode WP. Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial). BMC Pediatr. 2018 Aug 4;18(1):262. doi: 10.1186/s12887-018-1215-7.

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Indications