Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Description of compliance
研究概览
简要总结
This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and children up to 17 years of age (i.e. 18 years minus 1 day) with drug-resistant epilepsy.
This study is being conducted according to standard medical practice. No change in diagnostic or therapeutic management habits is imposed by this study. Quality of life questionnaires are the only additional procedures for this research.
详细描述
NUTRICIA has developed the KetoCal® range (4:1 and 3:1), a food for special medical purposes (DADFMS), to help healthcare professionals and patients establish and maintain a CR. KetoCal® 4:1 features a 4:1 ratio of fat to (carbohydrate + protein), while containing vitamins, minerals, trace elements and fiber. Similarly, KetoCal® 3:1 has a 3:1 ratio of lipids / (carbohydrates + proteins), while containing vitamins, minerals, trace elements and fiber. The KetoCal® range can be consumed orally, as a drink after dilution in hot water, incorporated as an ingredient in a recipe or administered by enteral feeding tube.
The KEOPS study is designed to gather real-life data on the therapeutic value of using the KetoCal® range in the management of drug-resistant epilepsy in infants (from 5 months) and children up to 18 years of age. Patients will be managed according to standard care practices. Initiation of ketogenic dieting will be at the investigator's discretion during the child's hospitalization.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants from 5 months and children up to 17 years of age (maximum 18 years minus 1 day).
- •With drug-resistant epilepsy according to ILAE (International League Against Epilepsy) criteria: persistence of epileptic seizures after failure of two appropriate antiepileptic drugs tried consecutively or in well-tolerated combination.
- •Indication for CR by a physician.
- •Parents (or legal guardians) able to set up and follow the diet, assessed during a joint doctor-dietician consultation.
- •Written authorization from one (or both) parents or the child's legal representative to collect personal information about their child.
- •Affiliation of the infant/child with the social security system.
排除标准
- •Contraindication to ketogenic diet at initial assessment.
- •Children already on a ketogenic diet.
- •Parenteral nutrition.
- •Concurrent prescription of other foodstuffs intended for special medical purposes (DADFMS) such as KetoVie or Keyo.
- •Protected legal representative (under legal protection, or deprived of liberty by judicial or administrative decision).
- •Legal representative not covered by a social security scheme.
- •Legal representative unable to understand study protocol.
- •Ancillary study eligibility criteria :
- •Patients included in the study.
- •Continued on the ketogenic diet for at least 2 months.
- •Having consented to participate in the ancillary study.
结局指标
主要结局
Description of compliance
时间窗: 6 months
Retention rate which is defined as the proportion of patients who have continued KD for up to 6 months.
次要结局
- KD tolerance.(From inclusion to Month 6)
- Duration of compliance(From Month 1 to Month 6)
- Efficacy of KD(From Month 1 to Month 6)
- Influence of KD(From inclusion to Month 6)
- Ketosis achievement(From inclusion to Month 6)
- QoL evolution(From inclusion to Month 6)