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

Not Applicable

Completed

Conditions: Topic: Neurological, Generic Health Relevance and Cross Cutting Themes
Subtopic: Neurological (all Subtopics), Generic Health Relevance (all Subtopics)
Disease: Nervous system disorders, Paediatrics
Nervous System Diseases
Cerebral palsy

Registration Number: ISRCTN15239951

Lead Sponsor: Clinical Trials and Research Governance (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurodevelopmental 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

Name	Time	Method
1. Growth: assessed using anthropometry carried out every 3 months (weight, height, skinfold measurements and head circumference)<br>2. Electrophysiology: Visual Evoked Potential and behavioural vision testing ? tested at baseline, 12 months post term, 24 months post term, 42 months post term<br>3. Neuroimaging: changes of brain biochemistry and choline uptake as estimated by MRS once at the end of the study<br>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<br>5. Corticospinal axon diameter: assessed by transcranial magnetic stimulation and will be done at baseline and at the end of the study