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Authors
Breindahl, Niklas https://orcid.org/0000-0003-3016-3567
Henriksen, Tine Brink
Heiring, Christian
Bay, Emma Therese
Haaber, Jannie
Salmonsen, Tenna Gladbo
Agergaard, Peter
Carlsen, Emma Louise Malchau
Tolsgaard, Martin Grønnebæk
Aunsholt, Lise
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Article History
Received: 18 December 2024
Revised: 13 June 2025
Accepted: 23 June 2025
First Online: 2 August 2025
Competing interests
: The authors declare no competing interests.
: The Committee on Health Research Ethics in the Region of Southern Denmark approved the trial protocol for deferred consent (approval number H-21078489),20 and infants were enrolled in the NONA-LISA feasibility study using deferred consent with an opt-out approach. Written informed consent was obtained from the infant’s legal guardians as soon as possible after enrolment.20 The Danish Data Protection Agency approved the study protocol (approval number P-2022-594). An independent Data Management and Ethical Committee reviews the progression and safety of the NONA-LISA trial. The NONA-LISA trial was prospectively registered on clinicaltrials.gov (NCT05609877) on October 18, 2022.
