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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04418440
Study type Interventional
Source Queen Mary University of London
Contact
Status Active, not recruiting
Phase N/A
Start date October 14, 2021
Completion date September 30, 2023

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