DOLFIN - Developmental Outcomes of Long Term Feed Supplementation in Neonates

DOLFIN aims to answer the research question:

In babies with a brain injury, does nutritional supplementation with a novel nutritional supplement plus usual care from birth to 12 months of age corrected for prematurity improve cognitive development at 2 years of age corrected for prematurity?

DOLFIN is a multicentre blinded randomised placebo-controlled trial with an integral internal pilot and alongside economic evaluation. The trial population will be two clearly defined groups:

• Babies born less than 28 weeks of gestation (preterm group)
• Babies born at 35 weeks of gestation or more, receiving therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE group)

The study aims to recruit 1,010 babies (538 to the preterm group and 472 to the HIE group) from 30 UK NHS tertiary Neonatal Units.

Babies will be randomised to either:-

• Treatment supplement: Micronutrient breast milk/formula milk/food supplement containing docosahexaenoic acid (DHA), choline and uridine-5-monophosphate (UMP) for babies with perinatal brain injury

or

• Matched placebo control supplement

Powder supplement will be added daily to usual milk feed (breast or formula) on the neonatal unit when infants reach full milk feeds (120-150ml/kg/day). Supplementation will be continued on discharge until one year of age corrected for prematurity.

DOLFIN is taking place between September 2021 and May 2027, with recruitment starting in 2022.

DOLFIN is managed by the National Perinatal Epidemiology Unit Clinical Trial Unit (NPEU CTU) at the University of Oxford and sponsored by The Newcastle Upon Tyne Hospitals NHS Foundation Trust. The Chief Investigators are Professor Jeremy Parr (University of Newcastle upon Tyne) and Dr Morag Andrew (Newcastle Upon Tyne Hospitals NHS Foundation Trust)