Babies who are born very early, or who suffer poor blood supply or lack of oxygen to the brain before or around birth, are more likely to have problems with their brain development and child neurological development. This may affect how children think and learn, communicate, play, and interact with the world around them.
DOLFIN aims to answer the research question:
In babies who are born very early or who suffer poor blood supply or lack of oxygen to the brain before or around birth, does giving a nutritional supplement daily for a year improve long-term cognitive development?
DOLFIN is a multicentre blinded randomised placebo-controlled trial. The trial population will be made up of two 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 trial aims to recruit 1,010 babies from around 30 neonatal units across the UK.
DOLFIN is taking place between September 2021 and May 2027. Recruitment started in October 2022.
The DOLFIN trial was set up by NHS clinicians and University academics who were successful in their application to an NIHR commissioned call. DOLFIN has involved peer and board review including an independent ethical review. The trial is overseen by an independent Steering Committee including NHS clinicians. Parents have been involved in all stages of the research – from funding application, to trial design. Parents continue to contribute as part of the research team.
DOLFIN is managed by the National Perinatal Epidemiology Unit, Clinical Trials 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 (Newcastle University) and Dr Morag Andrew (Newcastle upon Tyne Hospitals NHS Foundation Trust).