Prospective National Observatory for Cow's Milk Protein Allergy.
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Nutricia Nutrition Clinique
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Number and proportion of symptoms
概览
简要总结
The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed.
The Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.
详细描述
This is a prospective, observational, descriptive, longitudinal, multicentric study aimed at describing a cohort of infants with a recently suspected or confirmed allergy to cow's milk protein, who were treated in outpatient and inpatient settings.
The recruitment of patients eligible for this observatory will be done via community medicine (private practices of pediatricians and general practitioners) as well as in hospitals throughout France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants up to and including 8 months (up to 8 months and 29 days).
- •Initial diagnosis of allergy to cow proteins, suspected (clinical presumption) or confirmed.
- •Prescription of the substitution formula Pepticate® Syneo, according to the doctor's judgement, whether the child is under mixed or weaned breastfeeding.
- •Authorisation from a legal representative for the child to take part in the observatory and to collect personal information about the child and the family.
- •Membership of the social security system.
排除标准
- •Infants who have already received partial or total replacement infant formula (regardless of the type of infant formula).
- •Contraindication to the use of symbiotics (short small intestine, parenteral nutrition, post-pyloric feeding, central venous catheter) due to the use of Pepticate® Syneo®.
- •Diagnosis of severe cow protein allergy requiring an infant amino acid formula from the outset.
- •The child's legal guardian is protected (under legal protection, or deprived of liberty by judicial or administrative decision).
- •The legal representative is unable to understand the study protocol.
结局指标
主要结局
Number and proportion of symptoms
时间窗: 5 years
Numbers and proportion of symptoms (cutaneous, gastrointestinal, respiratory...), and their evolution according to the different forms of cow protein allergy: immediate Immunoglobulin E mediated, delayed non-Immunoglobulin E mediated or mixed and acute food protein-induced enterocolitis syndrome.
次要结局
未报告次要终点