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临床试验/ACTRN12617001195347
ACTRN12617001195347已完成未知

A comparison-group intervention study of medically supervised clinics for first peanut consumption compared with standard care to evaluate rates of introduction of peanut by 12 months of age in infants at risk of peanut allergy.

Child and Adolescent Health Service0 个研究点目标入组 350 人开始时间: 2017年8月16日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
350

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
4 Months 至 13 Months(—)
性别
All

入选标准

  • For the intervention group: Infants between 4 and 11 months of age who have never eaten peanut in solid foods, and are deemed as high-risk for the development of peanut allergy (classified as any one of the following):
  • Eczema treated with over the counter steroids or prescription medications
  • Allergy to a food other than peanut
  • Food allergy in a parent or sibling
  • Any atopic disease (eczema, asthma, food allergy, or allergic rhinitis/hay fever) in 2 or
  • more first degree relatives (parents/siblings)
  • For infants in the control group: Infants who are at least 12 months of age, have not attended a PIPPA clinic, and are deemed as high-risk for the development of peanut allergy (classified as any one of the following):
  • Eczema treated with over the counter steroids or prescription medications
  • Allergy to a food other than peanut
  • Food allergy in a parent or sibling
  • Any atopic disease (eczema, asthma, food allergy, or allergic rhinitis/hay fever) in 2 or
  • more first degree relatives (parents/siblings)

排除标准

  • Infants with significant underlying medical conditions that place them at increased risk
  • of adverse outcomes in the event of an allergic reaction, such as cardiovascular or
  • respiratory diseases. A study doctor will review these infants before enrolling them in
  • Infants who have had previous allergy testing (skin prick or specific IgE testing) for
  • peanut and been advised by, or in consultation with, a paediatrician or allergy specialist
  • to avoid peanut.

研究者

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