Deferm, Neel
Annink, Kim V.
Faelens, Ruben
Schroth, Michael
Maiwald, Christian A.
Bakkali, Loubna el
van Bel, Frank
Benders, Manon J. N. L.
van Weissenbruch, Mirjam M.
Hagen, Anja
Smits, Anne
Annaert, Pieter
Franz, Axel R.
Allegaert, Karel http://orcid.org/0000-0001-9921-5105
Franz, Axel R.
Rüdiger, Mario
Poets, Christian F.
Benders, Manon
van Bel, Frank
Allegaert, Karel
Naulaers, Gunnar
Bassler, Dirk
Klebermass-Schrehof, Katrin
Vento, Maximo
Guimaraes, Hercilia
Stiris, Tom
Mauro, Isabella
Metsäranta, Marjo
Vanhatalo, Sampsa
Mazela, Jan
Metsvaht, Tuuli
Jacobs, Yannique
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Glomerular Filtration Rate in Asphyxiated Neonates Under Therapeutic Whole-Body Hypothermia, Quantified by Mannitol Clearance
https://doi.org/10.1007/s40262-021-00991-6
Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia
https://doi.org/10.1136/archdischild-2023-325900
Funding for this research was provided by:
H2020 European Research Council (call H2020-PHC-2015-two-stage, grant 667224)
Article History
Accepted: 28 January 2021
First Online: 21 February 2021
Declarations
:
: The ALBINO project is funded under the Horizon 2020 Framework EU Program call H2020-PHC-2015-two-stage, grant 667224. The research on the pharmacokinetics during whole body hypothermia (Karel Allegaert, Pieter Annaert, Anne Smits) is further supported by the iPREDICT project (FWO Senior research project, fundamental research, G0D0520N).
: Neel Deferm, Kim V. Annink, Ruben Faelens, Michael Schroth, Christian A. Maiwald, Loubna el Bakkali, Frank van Bel, Manon J.N.L. Benders, Mirjam M. van Weissenbruch, Anja Hagen, Anne Smits, Pieter Annaert, Axel R. Franz, and Karel Allegaert have no conflicts of interest that are directly relevant to the content of this article. Yannique Jacobs is a collaborator within the ALBINO project and is an employee of ACE Pharmaceuticals, Zeewolde, the Netherlands, which holds the Dutch marketing authorization registration for Acepurin<sup>®</sup> (allopurinol 1 g/100 mL) for intravenous application for the treatment of gout.
: The Medical Ethics Committee of the University Medical Centre Utrecht and the Central Committee on Human Research approved the study including the specific pharmacokinetic sub-study for the Netherlands (NL57237.041.16). The German Federal Authority (EudractCT 2016-000222-19) as well as the leading Ethics Committee of Tübingen approved the study for Germany.
: Oral consent was obtained from at least one parent before administering the study medication. After the first dose, but before the (potential) second dose, full written parental consent was obtained. In case parents did not sign the informed consent, blood samples already collected shortly after birth were destroyed.
: The raw data are available upon reasonable request by an e-mail to the corresponding author, while blinding for group allocation should be respected until the primary outcome analysis has been finalized.
: Protocol development and study conduct: KVA, MS, CM, LEB, FVB, MB, MVW, AH, AF; ethics and study registration: KVA, FVB, MB, AF; study recruitment and data collection: KVA, MS, CM, LEB, FVB, MB, MVW, AH, AF; modeling: ND, RF, AS, PA, KA; drafting of the manuscript: ND, RF, AS, PA, AF, KA. All authors have read and commented on the paper, and have approved the submitted version.