Document is current

Article History

Received: 25 October 2020

Accepted: 24 February 2021

First Online: 17 March 2021

Declarations

:

: The initial study protocol has been approved by the Medical Ethical Committee of the UMC Utrecht on August 17, 2016 and the final protocol amendment has been approved by the Medical Ethical Committee of the UMC Utrecht on August 20, 2020 (reference numbers: 15–213/M; NL49902.041.14). Future protocol amendments will be presented to the Medical Ethical Committee for approval before implementation. The custodial parent(s) of potentially eligible infants will be approached by one of the trained investigators and informed about the study as soon as possible after admission of the pregnant woman to the obstetric ward with symptoms of suspected preterm labour or as soon as possible after admission of the infant to the neonatal intensive care unit. Parent(s) will be given both verbal and written information. After an appropriate amount of time for consideration and the possibility to ask questions to the investigator or an independent neonatologist, the investigator will return to the custodial parent(s) to hear their decision. After written informed consent of the custodial parent(s) has been obtained infants will be screened and randomly allocated to receive either the test product or the control product. Parent(s) can withdraw all aspects of their consent at any time during the study. Additionally, an infant will discontinue participation if further participation is a health risk for the infant at supervising clinician’s discretion.

: Not applicable.

: Edith van den Hooven is employee of Danone Nutricia Research, Utrecht. The other authors have no competing interests to declare.