NCT03489733已完成不适用
The Effect of Low Protein, Extensively Hydrolyzed Infant Formula on Allergy Prevention in At-risk Infants up to 1 Year of Age: a Randomized, Double-blind, Controlled Intervention Study and the Long-term Effect on Allergy Prevention of Early Nutrition Given in the First 120 Days of Life in At-risk Infants Until the Child is 6 Years of Age
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,226
- 试验地点
- 14
- 主要终点
- Cumulative incidence of atopic dermatitis
研究概览
简要总结
A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 56 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term-born male and female infants (gestational Age ≥37+0, singleton birth)
- •Birth weight ≥ 2500 g and ≤ 4500 g
- •Age at enrollment: ≤ 56 days of life
- •At risk of developing atopic diseases
- •Free of atopy symptoms at Screening and at any time before randomization
- •Feeding regimen at any time before Screening (V1) and Baseline (V2, infants who will receive Interventional Product (IP)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. Neocate Infant), maltodextrin or glucose solution/gel; breastfeeding allowed
- •Subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. Subject's parents/caregivers will decide which feeding regimen will be used (IP or breast milk):
- •IP regimen (intervention or control group): only IP and breast milk until at least 120 days of life
- •breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life.
- •No other infant formulas or solid foods are allowed.
- •Written informed consent.
排除标准
- •Multiple births
- •Premature delivery (gestational age ≤ 36+6)
- •Neonatal illnesses that might have an impact on allergy development (based on Investigator's decision)
- •Significant congenital abnormalities
- •Participation in another clinical study with an IP or study method that would influence the outcome of this study
- •Reason to presume that the subject's parents/caregivers are unable to meet study plan requirements.
研究组 & 干预措施
Intervention Group
Experimental
Infant Formula with hydrolyzed protein and breast milk until at least 120 days of life
干预措施: Hydrolyzed Formula (Other)
Control Group
Experimental
Infant Formula with intact protein and breast milk until at least 120 days of life
干预措施: Control formula (Other)
Breast Fed Group
No Intervention
Exclusively breast ilk until at least 120 days of life
结局指标
主要结局
Cumulative incidence of atopic dermatitis
时间窗: 1 year
Presence of atopic dermatitis on physical examination
次要结局
未报告次要终点
研究者
研究点 (14)
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