Optimising nutrition to improve growth and reduce neurodisabilities in children with suspected or confirmed cerebral palsy

ISRCTN	ISRCTN15239951
DOI	https://doi.org/10.1186/ISRCTN15239951
Protocol serial number	6797
Sponsor	Clinical Trials and Research Governance (UK)
Funder	Sparks (UK)

Submission date: 23/04/2010
Registration date: 23/04/2010
Last edited: 05/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Angharad Vernon-Roberts
Scientific

Oxford University Department of Paediatrics
Level 2, Oxford Children's Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Optimising nutrition to improve growth and reduce neurodisabilities in children with suspected or confirmed cerebral palsy: a randomised interventional treatment trial
Study acronym	Dolphin Study 2
Study objectives	The purpose of this study is to identify as early as possible children with a suspected or confirmed clinical diagnosis of cerebral palsy, defined as: 'A group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour, by epilepsy, and by secondary musculoskeletal problems.' We will then institute a nutritional care programme that ensures optimal macro- and micro-nutrient intake over a critical period of brain development.
Ethics approval(s)	Oxford Research Ethics Committee B, 12/01/2009, ref: 08/H0605/155
Health condition(s) or problem(s) studied	Topic: Neurological, Generic Health Relevance and Cross Cutting Themes; Subtopic: Neurological (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Nervous system disorders, Paediatrics
Intervention	The intervention is in the form of a neurotrophic supplement containing docosahexanoic acid (DHA), uridine monophosphate (UMP) and choline, along with supportive vitamins and minerals. The control being used is an iso-caloric, iso-nitrogenous placebo substance. The active supplement or control will be taken once daily and added to feed or food. This can be taken orally or via a feeding tube and supplementation will continue for the whole 2 years of the study. Follow Up Length: 24 month(s).
Intervention type	Supplement
Primary outcome measure(s)	Neurodevelopmental outcome which will be assessed using the Bayley Scale of Infant Development performed at baseline and at 12 and 24 months in to the study.
Key secondary outcome measure(s)	1. Growth: assessed using anthropometry carried out every 3 months (weight, height, skinfold measurements and head circumference) 2. Electrophysiology: Visual Evoked Potential and behavioural vision testing tested at baseline, 12 months post term, 24 months post term, 42 months post term 3. Neuroimaging: changes of brain biochemistry and choline uptake as estimated by MRS once at the end of the study 4. Indices of general health status: Prevalence of epilepsy, feeding difficulties, clinically significant gastro-oesophageal reflux, constipation, number of chest infections (requiring antibiotics) and hospital admissions to be assessed every 3 months 5. Corticospinal axon diameter: assessed by transcranial magnetic stimulation and will be done at baseline and at the end of the study
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	18 Months
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Children between the ages of 6 to 18 months, either sex 2. Suspected or confirmed clinical diagnosis of cerebral palsy as defined below: 'A group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour, by epilepsy, and by secondary musculoskeletal problems.' 3. Parent or guardian who is willing to sign the consent form
Key exclusion criteria	1. Children with progressive neurological degenerative conditions 2. Children with significant gastrointestinal disease 3. Parents considered by clinicians to be unable to follow the study protocol
Date of first enrolment	01/12/2008
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Oxford University

Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	17/03/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes