Neurodisabilities in neonates Nervous System Diseases
Conditions
Interventions
The intervention is in the form of a neurotrophic supplement containing docosahexanoic acid (DHA), uridine mono-phosphate (UMP) and choline, along with supportive vitamins and minerals. The control be
Sponsors
Oxford University Hospital Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion will depend on the presence of one or more of the following criteria: Birth =30+6 weeks gestation: 1. Small for gestational age - weight <9th centile 2. Grade II, III or IV Germinal Matrix Haemorrhage (GMH) - Intra Ventricular Haemorrhage (IVH) Birth 31-40+28 weeks gestation: 1. Grade II, III or IV Germinal Matrix Haemorrhage (GMH) - Intra Ventricular Haemorrhage (IVH) 2. Magnetic resonance imaging (MRI) scan abnormalities in posterior limb of the internal capsule (PLIC), Basal Ganglia or Thalami, White Matter and Cortex Encephalopathy supported by either: 1. Moderately abnormal amplitude-integrated electroencephalography (aEEG) 2. Sarnat Grade II or III
Exclusion criteria
Exclusion criteria: Exclusion will depend on the presence of one or more of the following criteria: Birth =30+6 weeks gestation: 1. Weight >9th centile 2. Grade I Germinal Matrix Haemorrhage (GMH) - Intra Ventricular Haemorrhage (IVH) 3. Profound hearing loss such that Bayley Assessment cannot be completed 4. Progressive neurological degenerative conditions 5. Gastrointestinal disease which significantly impairs absorption 6. Multiple congenital abnormalities or syndromic associations 7. Parents considered by clinicians to be unable to follow the study protocoL Birth 31-40+28 weeks gestation: 1. Grade I Germinal Matrix Haemorrhage (GMH) - Intra Ventricular Haemorrhage (IVH) 2. Profound hearing loss such that Bayley Assessment cannot be completed 3. Progressive neurological degenerative conditions 4. Gastrointestinal disease which significantly impairs absorption 5. Multiple congenital abnormalities or syndromic associations 6. Parents considered by clinicians to be unable to follow the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Neurodevelopmental outcome as assessed by using the Bayley Scale of Infant Development. A clinically significant improvement translates as ~10 points on the Bayley Scale (assuming Standard Deviation (SD) of ~12) 2. Growth measure as assessed using anthropometry (weight, height, skinfold measurements and head circumference) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Electrophysiology: Visual Evoked Potential and behavioural vision testing - tested at baseline, term (if applicable), 6, 12 and 24 months post entry into study 2. Neuroimaging: changes of brain biochemistry and choline uptake as estimated by Magnetic Resonance Spectroscopy (MRS) at baseline and 3 month follow-up | — |
Countries
United Kingdom
Outcome results
None listed