KCE-16013: Multizentrische, randomisierte Studie zur Bewertung der Nichtunterlegenheit einer frühzeitigen Behandlung gegenüber keiner Behandlung bei Frühgeborenen mit persistierendem Ductus arteriosus - BeNeDuctus-Studie

Trial Description
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

Open to recruitment

 

Trial team

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

Dokumente
Protocol https://neonatologynetwork.eu/studies/study-protocol
Report

Expected for Q2 2022

Publication

Expected for Q2 2022

Referenzen

ClinicalTrials.gov: NCT02884219

EudraCT: 2017-001376-28

Webpage: https://neonatologynetwork.eu/studies/beneductus

FINANZIERUNGSSCHEMA

Commissioning workstream 2016