Janson, E.
Koolschijn, P. C. M. P.
Schipper, L.
Boerma, T. D.
Wijnen, F. N. K.
de Boode, W. P.
van den Akker, C. H. P.
Licht-van der Stap, R. G.
Nuytemans, D. H. G. M.
Onland, W.
Obermann-Borst, S. A.
Dudink, J.
de Theije, C. G. M.
Benders, M. J. N. L.
van der Aa, N. E.
Article History
Received: 18 May 2023
Accepted: 22 May 2024
First Online: 7 June 2024
Declarations
:
: The initial study protocol has been approved by the Medical Ethical Committee of the UMC Utrecht on October 28th, 2021 (reference numbers 21–504/G; NL72700.041.21). Protocol amendments will be presented to the Medical Ethical Committee for approval before implementation. The study will be conducted in accordance with the study protocol, the ethical principles of the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, EU directives and the applicable local/national regulatory requirements, including the Medical Research Involving Human subjects Act (WMO).
: Caregivers of eligible infants will be approached by one of the trained investigators and informed about the study prior to discharge on one of the participating neonatal intensive care units. Caregivers will obtain both verbal and written information about the study. After an appropriate amount of time for consideration and the possibility to ask questions, caregivers can make their own decision on whether or not to participate. Written Informed Consent will be obtained from the parents/guardian of the infants for the study. Caregivers can withdraw at any time of the study, without needing to provide a reason. In addition, infants will drop-out of the study if continued participation is a health risk for the infant.
: Not applicable.
: Nutricia Research is one of the funding parties. Authors P.C.M.P.K. and L.S. are employed by Nutricia Research and were involved in the design of the study. Other authors declare no conflict of interest.