A Retrospective and Comparative Study on the Journey of Children With Cow´s Milk Protein Allergy in Mexico: Current Practice in Allergy Management in Mexican Children Aged ≤24 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- Dermatological symptoms (SCORAD score)
研究概览
简要总结
To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e. diagnosis and dietary management) of CMPA in Mexican children (≤24 months) diagnosed with or suspected of CMPA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with electronic/physical medical records that contain sufficient data to answer the primary question (i.e. data on growth and dermatological symptoms (based on the SCORAD score) at diagnosis and follow up data of at least 2 months or successful completion of therapy according to the PI (whichever comes first).
- •Subjects ≤24 months of age at the moment of suspected or diagnosed CMPA with records available between January 2016 to September
- •Subjects prescribed with Frisolac Gold Intensive HA and/or Frisolac Gold PEP AC for the dietary management of their CMPA symptoms.
排除标准
- •Subjects using other formula products/breast milk alongside Frisolac Gold Intensive HA or Frisolac Gold PEP AC during the time of their participation in the study.
- •Premature children, or children with low birth-weight (weight at birth <2.5 kg).
- •Subjects diagnosed with a metabolic condition that impacts development and growth.
- •Subjects diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the PI could potentially interfere with their participation in the study.
结局指标
主要结局
Dermatological symptoms (SCORAD score)
时间窗: Can be 2 weeks up to 2 months
The proportion of subjects with an 1-point improvement in their SCORAD intensity category in between 2 visits (%)
Growth
时间窗: Can be 2 weeks up to 2 months
* the proportion of subjects with weight gain compared to the previous visit (%) * the proportion of subjects with height gain compared to the previous visit (%) * the proportion of subjects with both weight and height gain compared to the previous visit (%)
次要结局
- Severity of symptoms(Can be 2 weeks up to 2 months)
- Type of symptoms(Can be 2 weeks up to 2 months)
- Number of symptoms(Can be 2 weeks up to 2 months)