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
Secondary identifying numbers 6797
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

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOptimising nutrition to improve growth and reduce neurodisabilities in children with suspected or confirmed cerebral palsy: a randomised interventional treatment trial
Study acronymDolphin Study 2
Study objectivesThe 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) studiedTopic: Neurological, Generic Health Relevance and Cross Cutting Themes; Subtopic: Neurological (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Nervous system disorders, Paediatrics
InterventionThe 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 typeSupplement
Primary outcome measureNeurodevelopmental 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.
Secondary outcome measures1. 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
Overall study start date01/12/2008
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit18 Months
SexBoth
Target number of participantsPlanned Sample Size: 60
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2008
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Oxford University
Oxford
OX3 9DU
United Kingdom

Sponsor information

Clinical Trials and Research Governance (UK)
University/education

Oxford University
Oxford University Research Services
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom

http://www.ox.ac.uk/
ROR logo https://ror.org/052gg0110

Funders

Funder type

Charity

Sparks (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Sparks Charity
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
BMC - Part of Springer Nature Springer Nature