Nutritional Treatment for the Amelioration of Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Feasibility to conduct the protocol as stated
研究概览
简要总结
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.
详细描述
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:
- Usual standard NHS care (control group)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult between 18 yrs and 80 yrs of age
- •Acute traumatic brain injury with confirmed radiological features
排除标准
- •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
结局指标
主要结局
Feasibility to conduct the protocol as stated
时间窗: 10 months
To assess logistical issues which might prevent a fully powered study being carried out using this protocol. The investigators will primarily be looking at retention rate. If there is an attrition rate of over 80% then this protocol will be deemed not feasible.
次要结局
- Brain network connectivity(10 months)
- Plasma phospholipid levels(10 months)
- Cognitive function(10 months)
- Inflammatory markers(10 months)
- Omega-3 index(10 months)
- Neurofilament light levels(10 months)
- C-reactive protein(10 months)