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

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

Abstract Background Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in P...

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Bibliographic Details
Main Authors: Tim Hundscheid, Rogier Donders, Wes Onland, Elisabeth M. W. Kooi, Daniel C. Vijlbrief, Willem B. de Vries, Debbie H. G. M. Nuytemans, Bart van Overmeire, Antonius L. Mulder, Willem P. de Boode, on behalf of the BeNeDuctus trial study group
Format: Article
Language:English
Published: BMC 2021-09-01
Series:Trials
Subjects:
Prematurity
Patent ductus arteriosus
Neonatal intensive care unit
Ibuprofen
Expectant management
Ductal ligation
Online Access:https://doi.org/10.1186/s13063-021-05594-x

Internet

https://doi.org/10.1186/s13063-021-05594-x

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