Chu, Wan-Yu
Nijman, Maaike
Stegeman, Raymond
Breur, Johannes M. P. J.
Jansen, Nicolaas J. G.
Nijman, Joppe
van Loon, Kim
Koomen, Erik
Allegaert, Karel
Benders, Manon J. N. L.
Dorlo, Thomas P. C.
Huitema, Alwin D. R.
,
Beynum, Ingrid M. van
ten Cate, Floris E. Udink
Helbing, Willem A.
Taverne, Yannick J. H. J.
de Boode, Willem P.
Bogers, Ad J. C. C.
Joosten, Koen F. M.
van de Woestijne, Pieter C.
de Liefde, Inge I.
van Dijk, Antony
Meijer, Natasja I. F.
Simons, Sinno H. P H. P.
van der Lee, Robin
Cornette, Jérôme M. J.
van Haren, Neeltje E. M.
Bos, Arend F.
Berger, Rolf M. F.
Accord, Ryan E.
Arrigoni, Sara C.
Duin, Leonie K.
Kneyber, Martin J. J.
Kooi, Elisabeth M. W.
van der Maaten, Joost M. A. A.
Meiners, Linda C.
Mebius, Mirthe J.
Marchie, Gideon J. du Sarvaas
Vanagt, Ward Y.
Claessens, Nathalie H. P.
van Wijk, Bram
Schoof, Paul H.
Talacua, Hanna
Steenhuis, Trinette J.
ter Heide, Henriette
van Iperen, Gabrielle G.
Bosch, Rian
Groenendaal, Floris
Derks, Jan B.
de Heus, Roel
Bekker, Mireille N.
Wösten-van, Roelie M. Asperen
Haaren, Nicole van Belle-van
Cianci, Daniela
Nikolakopoulos, Stavros
Roes, Kit C. B.
Lalmohamed, Arief
Rademaker, Karin
Ardine de Wit, G.
Funding for this research was provided by:
ZonMw (848042002)
Hartekind foundation
Friends of the Wilhelmina Children’s Hospital foundation
Article History
Accepted: 4 July 2024
First Online: 15 August 2024
Declarations
:
: The CRUCIAL study is funded by ZonMw, as part of the Goed Gebruik Geneesmiddelen, Grote Trials Ronde II program (; project number 848042002), the Hartekind Foundation (), and Friends of the Wilhelmina Children’s Hospital Foundation ().
: Wan-Yu Chu, Maaike Nijman, Raymond Stegeman, Johannes M. P. J. Breur, Nicolaas J.G. Jansen, Joppe Nijman, Kim van Loon, Erik Koomen, Karel Allegaert, Manon J.N.L. Benders, Thomas P.C. Dorlo, and Alwin D.R. Huitema have no conflicts of interest to declare that may be relevant to the contents of this article.
: 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 and secondary outcome analyses have been finalized.
: The codes are available upon reasonable request.
: RS, MN, MB, JB, NJ, JN, KvL, EK, and the CRUCIAL study group were responsible for protocol development, study conduct, study registration, study recruitment, and data collection. Population PK modeling was performed by WC, KA, TD, and AH. The draft of this manuscript was written and reviewed by WC, MN, KA, TD, and AH. All authors and contributors have read and commented on the manuscript and have approved the submitted version.
: The CRUCIAL trial (EudraCT 2017-004596-31; ClinicalTrials.gov NCT04217421) was conducted according to the principles of the Helsinki Declaration (2013). The trial was approved by the Medical Research Ethical Committee of UMC Utrecht (reference number NL62772.041.18) and the Dutch national competent authority Central Committee on Research Involving Human Subjects (reference number NL62772.041.18).
: Not applicable.
: Written informed consent was collected from all parents or legal guardians before study participation. Parents were informed about the study by the obstetrician or fetal cardiologist between 24 and 36 weeks of gestation and were asked for written consent before the start of delivery.