Topic: Neurological, Generic Health Relevance and Cross Cutting Themes
Conditions
Interventions
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 bei
Sponsors
Clinical Trials and Research Governance (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed