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Article History

Received: 1 April 2025

Accepted: 21 October 2025

First Online: 29 December 2025

Declarations

:

: The DOLFIN trial has received approval from the MHRA and the NHS Health Research Authority (Ethics Ref: 22/SW/0009) and the South West–Central Bristol Research Ethics Committee. Informed consent will be obtained for all participants.Trust Confirmation of Capacity and Capability will be secured at each participating site. The CI or their delegate will submit the Annual Progress Report, End of Trial Notification, and Final Report to key stakeholders, including the Funder (NIHR HTA), MHRA, REC, HRA, host organisation, and Sponsor.

: Not applicable. This trial protocol does not involve the use of any personal details, images, videos, or other materials that would require consent from participants or their authorised surrogates.

: PH is a member of the NIHR Health Technology Assessment Funding Committee (commissioning). NE declares research funding paid to his institution for NIHR portfolio adopted trials from Prolacta Biosciences US, Nutricia Early Life Nutrition, ELGAN pharma, and Neokare UK but did not receive personal fees. NE has received speaker’s honoraria from Nestle Nutrition Institute and for providing consultancy advice to legal firms involved in class action for necrotising enterocolitis in the US; these monies have been donated to charity. NE has provided non-remunerated advice to the WHO, ESPGHAN, and BAPM in the areas of human milk and nutrition for preterm infants. MA declares speaker honoraria from Nestle Nutrition Institute and ESPGHAN conference travel and accommodation costs for the presentation of the Dolphin RCT findings from Nutricia UK, and symposia speaker travel and accommodation costs from Danone Research and Innovation centre.