Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases With Dietary Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Feeding scale score
研究概览
简要总结
The main objective of this study is to estimate the prevalence of Pediatric Eating Disorders (PED) in Inherited Metabolic Diseases (IMD) with dietary treatment between the age of 12 months and 6 years 11 months.
详细描述
Inherited Metabolic Diseases (IMDs) are rare conditions, which are the consequence of a genetic defect affecting an enzyme or a transporter involved in metabolism. This enzymatic defect leads to the accumulation of a potentially toxic compound located upstream of the deficiency and/or the absence of a compound located downstream of the defect. Treatment is possible and it consists of dietary and/or drug treatment.
Pediatric Eating Disorders (PED) cover "all the difficulties of oral feeding. These may be disorders due to absence of spontaneous feeding behavior, or refusal to eat, and disorders which affect the child's entire psychomotor, language and emotional development.
To date, the investigators note the absence of data on the prevalence of PED in IMDs and more generally on the quality of life and psychomotor development of these patients.
The causes and mechanisms of PED are numerous and heterogeneous. Their origins can be endogenous and/or exogenous.
Our main hypothesis is that the presence of PEDs varies depending on the different categories of IMDs with dietary treatment. Estimating their prevalence would enable awareness and early, better quality care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient from 12 months to 6 years and 11 months old
- •Patient with an Inherited Metabolic Diseases with dietary treatment
- •Patient having experimented a dietary diversification at least 6 month prior
- •Patient whose parents do not object to their participation in the study
排除标准
- •Patient with an associated chronic disease
- •Patient with diagnosed Autistic Spectrum Disorder (ASD) or Pervasive Developmental Disorders (PDD)
- •Patient born before 36 weeks of amenorrhea
- •Patient with multiple disabilities
- •Patient with dystonia
- •Patient with absent or unstable head posture
- •Patient whose parents do not fully understand or speak French
结局指标
主要结局
Feeding scale score
时间窗: 1 day
MCH (Montreal Children's Hospital) feeding scale score between the age of 12 months and 6 years 11 months.
次要结局
- Risk factors identification(1 day)
- Disorders severity level differentiation(1 day)
- Paediatric eating disorders prevalence for each pathology(1 day)