Evidence map›Paper›PMID 41462322›Full record

ArticleTrials2025

Trial protocol: DOLFIN trial: Developmental Outcomes of Long-term Feed Supplementation in Neonates-A UK multicentre, blinded, stratified, randomised controlled trial.

Morag J Andrew, Nicholas Embleton, Pollyanna Hardy, Samantha Johnson, Edmund Juszczak, Heather Ledbury, Claire Pearson, Oliver Rivero-Arias, Adriana Amorim Francisco, Janet Berrington and 16 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Morag J AndrewPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK. morag.andrew@newcastle.ac.uk.ORCID http://orcid.org/0000-0003-2532-1655
Nicholas EmbletonPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
Pollyanna HardyNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Samantha JohnsonDepartment of Population Health Sciences, University of Leicester, Leicester, UK.
Edmund JuszczakNottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.
Heather LedburyPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
Claire PearsonPortsmouth Hospitals University National Health Service Trust, Portsmouth, UK.
Oliver Rivero-AriasNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Adriana Amorim FranciscoNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Janet BerringtonNewcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, UK.
Penny BradleyNewcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, UK.
Peter J BradleyBliss, 1st Floor North, 10-18 Union Street, London, SE1 1SZ, UK.
Christina ColeNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Kate CourtPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
Madeleine HurdNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Andrew KingNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Louise LinsellNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
David MurrayNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Heather M O'ConnorNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Charles C RoehrNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Victoria StalkerNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Kayleigh StanburyNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Usharani Devi WahengbamNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Richard WelshNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Joy WilesNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, UK.
Jeremy R ParrPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.

Funding

Health Technology Assessment Programme NIHR130925
6 · The paper itself

Abstract

backgroundInfants born extremely preterm (EP; < 28 weeks of gestation) or term born infants with hypoxic-ischemic encephalopathy (HIE) have increased risk of long-term cognitive and learning deficits. Early supplementation with long chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and arachidonic acid (ARA), choline, uridine-5'-monophosphate (UMP), and cytidine-5'-monophosphate (CMP), zinc, iodine, and vitamin B12 may improve cognitive and language outcomes in these populations.

methodsThis multicentre, blinded, stratified, randomised controlled trial, including an economic evaluation, will investigate the impact of nutritional supplementation on cognitive development in infants born EP or term born infants with HIE. The planned sample size is 1010 (538 EP, and 472 HIE) infants from up to 40 National Health Service neonatal units in the UK. The trial patient populations are infants born EP (preterm stratum) and term infants (born at or more than 35 weeks of gestation) with HIE who received therapeutic hypothermia (HIE stratum). Patient strata were chosen to include infants at high risk of adverse neurodevelopmental outcomes by virtue of EP birth, or HIE requiring therapeutic hypothermia. Infants are randomly assigned, in a 1:1 allocation ratio, to receive either the active supplement or a matched control, in addition to standard care. Families, clinical teams, investigators, and Clinical Trials Unit staff are blinded to allocation. Only the Senior Trials Programmer and Trial Statisticians have access to allocation information. The active supplement is a nutrient powder formulated to be mixed with breast milk, infant formula, or food, containing LCPUFAs (including DHA, EPA, and ARA), choline, UMP, CMP, zinc, iodine, and vitamin B12. Supplementation commences once infants achieve full milk feeds and continues until 12 months post-estimated date of delivery (EDD), with a daily dosage of 1 g per kilogram of body weight. The primary outcome is the Parent Report of Children's Abilities-Revised non-verbal cognitive scale at 24 months post-EDD. EP and HIE patient population comparisons have been appropriately powered and will be analysed separately. DISCUSSION: Findings from the DOLFIN trial will inform international neonatal and infant nutritional and feeding policy and practice. Learnings from the trial will inform the design and delivery of future neonatal nutritional intervention trials.

trial registrationISRCTN62323236. Registered 16 May 2022, https://www.isrctn.com/ISRCTN62323236 .

Indexed as

Child DevelopmentCognitionDietary SupplementsHypoxia-Ischemia, BrainInfant, Extremely PrematureInfant Nutritional Physiological PhenomenaFemaleGestational AgeHumansInfantInfant, NewbornMulticenter Studies as TopicRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeUnited KingdomBrainCholineCognitionDocosahexaenoic acidHypoxic ischaemic encephalopathyNeurodevelopmentNutrientNutritionPreterm

Identifiers

PMID41462322
PMCPMC12752120

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.