Condition category
Nervous System Diseases
Date applied
08/10/2012
Date assigned
09/11/2012
Last edited
05/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Docosahexaenoic acid (DHA), choline and uridine-5-monophosphate are dietary factors known to support healthy brain growth and development. These 'neurotrophic' factors are passed from a mother to her baby during pregnancy, with the highest levels being passed to the baby in the third trimester of pregnancy. Many people have diets lacking in these factors. In addition, babies born prematurely will not receive enough of these factors. Babies at risk of brain impairment may not have enough neurotrophic factors to allow the brain to perform natural repair processes, and to help support healthy brain growth and development. Children with brain impairment can also grow less well than children without brain impairment. The aim of this study is to assess whether or not providing adequate amounts of neurotrophic factors can improve growth and developmental outcome in babies at risk of brain impairment.

Who can participate?
Babies at risk of brain impairment.

What does the study involve?
Newborn babies eligible to join the study will be randomly allocated to receive either an active supplement containing the neurotrophic factors or a placebo (dummy) that does not contain the neurotrophic factors. This supplement will be taken every day for 2 years. Neither the parents nor the research team will know whether the baby is on the active or placebo supplement. All babies in the study will also receive support from the study dietician to make sure that they receive a healthy balanced diet and to provide help and advice with supplement administration. During the 2-year study the growth and developmental progress of each baby will be followed by the research team. Participants will also have a blood test measuring DHA levels at the beginning and end of the study. A magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) scan assessing brain choline levels will be performed at the beginning of the study and at 3 months of age. A further MRI and MRS scan will also be performed at the end of the study in those children who need a scan for clinical reasons.

What are the possible benefits and risks of participating?
Babies who participate in the study may have improved growth and developmental outcome. The disadvantages of taking part are that the assessments and tests involved will require more time spent in hospital.

Where is the study run from?
Department of Paediatrics, University of Oxford (UK).

When is the study starting and how long is it expected to run for?
The study opened in September 2009 and will recruit participants until December 2012. The study will close in December 2014 when the last children taking part have completed their involvement with the study.

Who is funding the study?
The Castang Foundation (UK).

Who is the main contact?
Bonny Baker

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Sullivan

ORCID ID

Contact details

University of Oxford
Department of Paediatrics
Children's Hospital
John Radcliffe
Headley Way
Oxford
OX3 9DU
United Kingdom
-
peter.sullivan@paediatrics.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9348

Study information

Scientific title

Optimising nutrition to improve growth and reduce neurodisabilities in neonates at risk of neurological impairment: a randomised interventional treatment trial

Acronym

Study hypothesis

Dietetic and nutritional intervention that optimises macro and micro-nutrient intake will improve growth and neurodevelopmental outcomes in neonates who are at risk of neurological impairment.

Ethics approval

Oxford Research Ethics Committee, 13/08/2008, ref: 08/H0605/70

Study design

Double-blind 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

Neurodisabilities in neonates

Intervention

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 being used is an iso-caloric, iso-nitrogenous placebo substance.

The active supplement or control will be taken 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

Drug

Phase

Not Applicable

Drug names

Docosahexanoic acid (DHA), uridine mono-phosphate (UMP) and choline

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/08/2008

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned Sample Size: 60

Participant 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

Recruitment start date

01/08/2008

Recruitment end date

01/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Oxford University Hospital Trust (UK)

Sponsor details

c/o Heather House
Research and Development Lead
Research and Development Department
Joint Research Office
Block 60
Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom
+44 (0)1865 572245
heather.house@ouh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Charity

Funder name

Castang Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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