NCT06065904尚未招募不适用
Exploring the Efficacy of a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD: A Randomized Controlled Trial at a Single Center
Silviya Pavlova Nikolova, PhD0 个研究点目标入组 200 人开始时间: 2023年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- bedridden days monthsmean duration of bedridden days over six months
研究概览
简要总结
The study is a prospective, single-center, randomized controlled trial that will be conducted at the Medical University of Varna. This setting offers access to a wealth of clinical expertise in managing CP and ASD and a rich tradition of conducting robust nutritional interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A formal diagnosis made by a qualified neurologist. The diagnosis can span across the different types of CP and ASD.
- •Expressed willingness to participate in the study.
- •Availability for the entire duration of the study.
排除标准
- •Children with acute medical conditions or comorbidities that may significantly disrupt study assessments.
- •Any severe infections within the last 10 days prior to the study.
- •Presence of genetic syndromes that could influence nutritional status, e.g., Silver Russel syndrome or Down syndrome.
- •Parents with cognitive impairments, which might pose challenges in their participation during assessments/intervention.
- •Children who have been part of any major dietary or nutritional interventions in the last three months.
结局指标
主要结局
bedridden days monthsmean duration of bedridden days over six months
时间窗: six months
mean duration of bedridden days
次要结局
- Number of social interactions per week with non-family members(six months)
- Height-for-Age Z-Score(six months)
- Number of Leisure Activities per Month(six months)
- BMI-for-Age Z-Score(six months)
- Weight-for-Age Z-Score(six months)
- Total Days of School or Kindergarten Attendance per month(six month)
- Total Number of New Spoken Words per Month(six months)
研究者
Silviya Pavlova Nikolova, PhD
The research is financed by the European Union-NextGenerationEU, through the National Recovery and Resilience Plan of the Republic of Bulgaria, project № BG-RRP-2.004-0009-C02.
Medical University of Varna
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