Nutritional Treatment for the Amelioration of Traumatic Brain Injury

Nutritional Treatment for the Amelioration of Traumatic Brain Injury

To test the feasibility of administering a commercially available neurotrophic oral nutritional supplement (ONS) for adult patients with acute traumatic brain injury at the Royal London Hospital.

The study will be a randomised controlled non-blinded trial of adult patients with acute traumatic brain injury at the Royal London Hospital.

There will be randomisation to one of two non-blinded trial groups:

1. Usual standard NHS care (control group)
2. Usual standard NHS care plus daily oral dose of Souvenaid® ONS

The trial protocol will commence between 3-7 days after admission. The trial timeline provides a summary of intervention and assessments.

The trial will last 12 months. The first 6 months will be the formal trial with two groups and follow up assessments. This will be performed on intention to treat basis. After this initial phase the investigators will provide an opportunity for all participants from either group (control or treatment) to take Souvenaid® ONS for a further 6 months with a clinical follow up appointment.

Inclusion Criteria:

• Adult between 18 yrs and 80 yrs of age
• Acute traumatic brain injury with confirmed radiological features

Exclusion Criteria:

• Allergies to fish oil/milk/soya
• Medical history of galactosaemia
• Non-traumatic aetiology to head injury
• Unable to receive enteral nutrition
• Craniectomy during admission (loss of integrity of skull convexity)
• Concurrent active neurological disease
• Pregnancy or breastfeeding