Academic Journal
Early treatment versus expectative management of patent ductus arteriosus in preterm infants : a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial)
| العنوان: | Early treatment versus expectative management of patent ductus arteriosus in preterm infants : a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial) |
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| المؤلفون: | Hundscheid, Tim, Onland, Wes, van Overmeire, Bart, Dijk, Peter, van Kaam, Anton H. L. C., Dijkman, Koen P., Kooi, Elisabeth M. W., Villamor, Eduardo, Kroon, André A., Visser, Remco, Vijlbrief, Daniel C., de Tollenaer, Susanne M., Cools, Filip, van Laere, David, Johansson, Anne-Britt, Hocq, Catheline, Zecic, Aleksandra, Adang, Eddy, Donders, Rogier, de Vries, Willem, van Heijst, Arno F. J., de Boode, Willem P. |
| المصدر: | BMC PEDIATRICS ; ISSN: 1471-2431 |
| سنة النشر: | 2018 |
| المجموعة: | Ghent University Academic Bibliography |
| مصطلحات موضوعية: | Medicine and Health Sciences, Pediatrics, Perinatology, and Child Health, Prematurity, Patent ductus arteriosus, Neonatal intensive care unit, Ibuprofen, Expectative management, Ductal ligation, Mortality, Necrotising enterocolitis, Bronchopulmonary dysplasia, Cost-effectiveness, LOW-BIRTH-WEIGHT, PLACEBO-CONTROLLED TRIAL, PROPHYLACTIC INDOMETHACIN THERAPY, RESPIRATORY-DISTRESS SYNDROME, BUDGET IMPACT ANALYSIS, PREMATURE-INFANTS, DOUBLE-BLIND, INTRAVENOUS IBUPROFEN, EARLY CLOSURE, BLOOD-FLOW |
| الوصف: | Background: Much controversy exists about the optimal management of a patent ductus arteriosus (FDA) in preterm infants, especially in those born at a gestational age (GA) less than 28 weeks. No causal relationship has been proven between a (haemodynamically significant) PDA and neonatal complications related to pulmonary hyperperfusion and/or systemic hypoperfusion. Although studies show conflicting results, a common understanding is that medical or surgical treatment of a FDA does not seem to reduce the risk of major neonatal morbidities and mortality. As the PDA might have closed spontaneously, treated children are potentially exposed to iatrogenic adverse effects. A conservative approach is gaining interest worldwide, although convincing evidence to support its use is lacking. Methods: This multicentre, randomised, non-inferiority trial is conducted in neonatal intensive care units. The study population consists of preterm infants (GA < 28 weeks) with an echocardiographic-confirmed PDA with a transductal diameter > 1.5 mm. Early treatment (between 24 and 72 h postnatal age) with the cyclooxygenase inhibitor (COXi) ibuprofen (IBU) is compared with an expectative management (no intervention intended to close a PDA). The primary outcome is the composite of mortality, and/or necrotising enterocolitis (NEC) Bell stage >= IIa, and/or bronchopulmonary dysplasia (BPD) defined as the need for supplemental oxygen, all at a postmenstrual age (PMA) of 36 weeks. Secondary outcome parameters are short term sequelae of cardiovascular failure, comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. Consequences regarding health economics are evaluated by cost effectiveness analysis and budget impact analysis. Discussion: As a conservative approach is gaining interest, we investigate whether in preterm infants, born at a GA less than 28 weeks, with a PDA an expectative management is non-inferior to early treatment with IBU ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| Relation: | https://biblio.ugent.be/publication/8683573; http://hdl.handle.net/1854/LU-8683573; http://dx.doi.org/10.1186/s12887-018-1215-7; https://biblio.ugent.be/publication/8683573/file/8683576 |
| DOI: | 10.1186/s12887-018-1215-7 |
| الاتاحة: | https://biblio.ugent.be/publication/8683573 http://hdl.handle.net/1854/LU-8683573 https://doi.org/10.1186/s12887-018-1215-7 https://biblio.ugent.be/publication/8683573/file/8683576 |
| Rights: | Creative Commons Attribution 4.0 International Public License (CC-BY 4.0) ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.47961CE3 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s12887-018-1215-7 |
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