KCE-16013: Multizentrische, randomisierte Studie zur Bewertung der Nichtunterlegenheit einer frühzeitigen Behandlung gegenüber keiner Behandlung bei Frühgeborenen mit persistierendem Ductus arteriosus - BeNeDuctus-Studie
(Niederländisch oder Französisch oder Englisch)
| Title |
Multi-center, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants. (KCE-16013) |
|
Participants (P) |
Preterm infants (GA<28 weeks) with an echocardiographic confirmed PDA with a transductal diameter >1.5 mm |
|
Intervention (I) |
Expectative PDA management is characterized as ‘watchful waiting’. No intervention is initiated with the intention to close a PD. |
|
Control (C) |
The preterm infants with a PDA are treated with COX-inhibition by Ibuprofen |
|
Outcome (O) |
The primary outcome is the composite of mortality, and/or NEC (Bell stage ≥ IIa), and/or BPD, defined as the need for supplemental oxygen need, all at a postmenstrual age of 36 completed weeks. |
|
Trial Design |
Multicenter, randomized, non-inferiority study conducted in neonatal intensive care units (NICU’s) in the Netherlands and Belgium |
|
Sample Size |
564 (150 in BE) |
|
Trial duration |
48 Months |
|
Budget |
€ 200 000 (incl. VAT) |
|
Status |
|
Sponsor |
Radboudumc Amalia Children’s Hospital |
|
Chief Investigator |
Willem P. de Boode, MD PhD Radboudumc Amalia Children’s Hospital Department of Pediatrics, Division of Neonatology Geert Grooteplein Zuid 10 6525 GA Nijmegen The Netherlands |
|
Belgian Coordinating Centre |
Bart Van Overmeire, MD PhD Hôpital Erasme Service de néonatologie Route de Lennik 808 1070 Bruxelles |
| Protocol | https://neonatologynetwork.eu/studies/study-protocol |
| Report |
Expected for Q2 2022 |
| Publication |
Expected for Q2 2022 |
