Optimising nutrition to improve growth and reduce neurodisabilities in neonates at risk of neurological impairment

Not Applicable

Completed

• Conditions: eurodisabilities in neonates; Nervous System Diseases

• Registration Number: ISRCTN39264076
• Lead Sponsor: Oxford University Hospital Trust (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25885548 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29806081

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-09
• Study Completion: 2015-03-04
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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)<br> 2. Growth measure as assessed using anthropometry (weight, height, skinfold measurements and head circumference)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Electrophysiology: Visual Evoked Potential and behavioural vision testing - tested at baseline, term (if applicable), 6, 12 and 24 months post entry into study<br> 2. Neuroimaging: changes of brain biochemistry and choline uptake as estimated by Magnetic Resonance Spectroscopy (MRS) at baseline and 3 month follow-up<br>