Table 2 Schedule of trial assessments

Feed supplementation

Daily

Both groups will receive a measured feed supplement (active or placebo) to add to a milk feed daily

Dietetic review

Every 2 weeks or as required

Dietetic review will take place in person or by telephone every two weeks or as required for the duration of the trial

Anthropometry

Every 3 months

Measurements will be taken using calipers and anthropometer at baseline and then every 3 months to monitor growth.

MRI/MRS

0 and 3 months

This scan will be performed at baseline and then three months later to assess brain chemistry and choline uptake.

Visual Event Related Potential and behavioural vision testing

Baseline, term, 6 m, 12 m, 24 m

During this test the child will be positioned on the parents lap or in a chair to view a monitor where moving black and white stripes were shown. For the test 3 adhesive electrodes will be placed on the head and connected to a computer by fine cables. The child will also be observed for reactions to moving stimuli and given simple tasks to perform

Bayley Assessment

Baseline, 12 and 24 months

The child will be asked to do a number of activities to see if their thinking, language, and moving (sitting, walking) skills are similar to children his or her own age.

Vineland Assessment

12 and 24 months

During a semi-structured interview the parents will be given a questionnaire to fill in about their child’s personal and social skills.

Fatty acid profile analysis

Baseline and 24 months

0.05mls of blood will be taken using a finger prick test.

Maternal fatty acid profile analysis

Baseline

0.05mls of blood will be taken using a finger prick test.