Condition category
Nervous System Diseases
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
05/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Angharad Vernon-Roberts

ORCID ID

Contact details

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

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 measures

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

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

http://www.ox.ac.uk/

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

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25885548

Publication citations

Additional files

Editorial Notes