A Post-intervention Follow-up of the Allergy Reduction Trial, to Investigate the Prolonged Risk Reducing Effect of a Partially Hydrolysed Infant Formula During the First Six Months of Life on Allergic Manifestations Up to the Age of 5 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 455
- 试验地点
- 3
- 主要终点
- Incidence of allergic Manifestations
研究概览
简要总结
The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen [formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.
详细描述
The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen [formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 63 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who were part of the Intention-to-Treat population of the A.R.T. study
- •Children of the A.R.T. study ITT population within the age range of 5 years up to 5 years and 3 months
- •Children of the A.R.T. study ITT population in whom at least one parent and/or legal guardian signed the written consent form
排除标准
- •Children who did not participate in the A.R.T. study or who were not assigned to any of the 3 study arms
- •Children of the A.R.T. study who are younger than 5 years of age or older than 5 years and 3 months of age
- •Children of the A.R.T. study in whom parents and/or guardians do not agree to provide a written consent form
结局指标
主要结局
Incidence of allergic Manifestations
时间窗: At 5 years of age
Incidence of allergic manifestations (AM) based on parental reporting using Childhood Allergy questionnaire comparing partially hydrolyzed protein formula, standard formula and exclusive breastfeeding.
次要结局
未报告次要终点