Russian Prospective Open Comparative in Two Groups, Low-interventional Study on the Effect of the Oral Nutrition Supplement (ONS) "Nutrinidrink With Dietary Fiber" on the Health Indicators in Children With Cerebral Palsy (CP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- BMI
研究概览
简要总结
The goal of this low-interventional study was to study the effect of additional nutritional support with ONS "Nutrinidrink with dietary fiber" on the anthropometric parameters of patients and the dynamics of gastrointestinal symptoms in patients with cerebral palsy. Among the additional objectives were to study the quality of life, metabolic parameters and the dynamics of some functional parameters of patients. Possible adverse events were also studied and described.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cerebral palsy, spastic and hyperkinetic forms;
- •Class of cerebral palsy GMFCS 2-3;
- •Z-score BMI ≤ -1;
- •The patient's ability to safely swallow liquid food;
- •Availability of informed consent signed by the patient's legal representative for inclusion in the study and processing of personal data.
排除标准
- •Individual intolerance to the investigational product components;
- •Galactosemia;
- •Allergy to cow's milk proteins and other food intolerances;
- •Participation in another clinical study currently or in the past 30 days;
- •Any other medical or non-medical reason that, in the physician's opinion, may prevent the patient from participating in the study.
- •Deterioration of the patient's condition requiring his transfer to enteral or parenteral nutrition;
- •Transfer of a patient to another hospital;
- •Complications that could be caused by the investigational product (diarrhea, nausea, vomiting, allergies, etc.);
- •Withdrawal for a safety reason
- •Refusal of the patient (his legal representative) from further participation in the study and withdrawal of informed consent to participate in the study and the processing of personal data. At the same time, the exclusion of a patient from the study should not affect the nature of his therapy
结局指标
主要结局
BMI
时间窗: during observation up to 16 weeks
Body Mass Index
Martinet-Kushelevsky test
时间窗: during observation up to 16 weeks
Activity test to determine the level of physical abilities
Gastrointestinal symptoms scale
时间窗: during observation up to 16 weeks
A patient reported 5 score questionnaire to evaluate frequency and severity of gastrointestinal symptoms with 1 - minimal symptom manifestation, 5 - maximal symptom manifestation
Z-score (BMI)
时间窗: during observation up to 16 weeks
Body mass index z-scores are measures of relative weight adjusted for child age and sex
Bioelectrical impedance analysis
时间窗: during observation up to 16 weeks
Device-based diagnostics to measure the voltage of weak electrical currents in order to calculate impedance (resistance) of the body
次要结局
未报告次要终点