Plomgaard, Anne Mette
Stevenson, Nathan
Roberts, James A.
Hvass Petersen, Tue
Vanhatalo, Sampsa
Greisen, Gorm http://orcid.org/0000-0001-8042-3262
Pellicer, Adelina
Fumagalli, Monica
Lemmers, Petra
Pichler, Gerhard
Dempsey, Eugene
Claris, Olivier
Hyttel-Sorensen, Simon
,
Article History
Received: 24 June 2022
Revised: 17 June 2023
Accepted: 7 July 2023
First Online: 27 July 2023
Competing interests
: J.A.R. and S.V. hold a licensed patent on the burst metrics used in this paper. The remaining authors have no conflicts of interest to report.
: The SafeBoosC-II trial including recording of EEG and 2-year follow-up was approved by local ethics committees: clinical research ethics committee of the Cork Teaching Hospitals (EMC 3 (xxx) 03/07/12); Ethikkommission Medizinische Universität Graz (24-261 ex (11/12)); De Videnskabetiske Komiteer—Region Hovedstaden (H-4-2012-028); CPP Sud-Est III—Lyon (HCL/P 2012.728); Direzione Scientifica-Comitato di Etica—The IRCCS Fondazione Ca’ Granda Ospedale Maggiore Policlinico (549/12-all.3); Medisch Ethische Toetsingscommissie—Universitair Medisch Centrum Utrecht (WAG/rc/12/ 036774); and Comité Ético de Investigación Clínica del Hospital Universitario ‘La Paz’ de Madrid (15/2011). Parents gave consent to the recording of EEG as part of the SafeBoosC-II trial. The trial was approved by research ethics committees in each hospital. The present re-use of the data was not deemed to require separate ethical approval since (a) the purpose of the study falls within the scope of the SafeBoosC-project, and (b) the new EEG analysis would be unable to reveal information that could be of importance to the subjects at the present time.