Mitteregger, Elena http://orcid.org/0000-0003-4484-083X
Dirks, Tineke
Theiler, Manuela
Kretschmar, Oliver
Latal, Beatrice
Funding for this research was provided by:
Anna Müller Grocholski-Stiftung
Article History
Received: 15 July 2022
Accepted: 1 December 2022
First Online: 23 December 2022
Declarations
:
: This study protocol (version 1.3, 01.02.2022) has been approved by the Cantonal Ethics Commission in Zurich, BASEC-Nr. 2019–01787, amendments 07.01.2020 and 15.02.2022 (Supplementary material InternalRef removed) and is registered at Clinicaltrials.gov NCTT04666857. Written informed consent will be obtained from all parents of included participants by EM (Supplementary material InternalRef removed). BL, the trial sponsor and EM, the investigator may terminate the study prematurely according to certain circumstances, e.g., ethical concerns, insufficient participant recruitment, when the safety of participants is doubtful or at risk or when there is early evidence of harm or benefit of the experimental intervention.
: Parents of included participants will be asked to give consent for the publication of this results of the feasibility study. Findings from this study will be published in peer-reviewed journals and presented at national and international conferences, to parent organizations, and to healthcare stakeholders for widespread dissemination of the results.
: The authors declare that they have no competing interests.