Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6797
Study information
Scientific title
Optimising nutrition to improve growth and reduce neurodisabilities in children with suspected or confirmed cerebral palsy: a randomised interventional treatment trial
Acronym
Dolphin Study 2
Study hypothesis
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
Oxford Research Ethics Committee B, 12/01/2009, ref: 08/H0605/155
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Docosahexanoic acid (DHA), uridine mono-phosphate (UMP), choline, vitamins, minerals
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
01/12/2008
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 60
Participant 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
Recruitment start date
01/12/2008
Recruitment end date
31/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford University
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Clinical Trials and Research Governance (UK)
Sponsor details
Oxford University
Oxford University Research Services
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Sparks (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25885548