DRKS00016462已完成未知
Growth and Tolerance of Healthy Term Infants Fed Infant Formula With 100% Whey Protein Hydrolysate or Intact Milk Proteins (Penguin Project)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 251
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- one 至 28 Days（—）
- 性别
- All
入选标准
- •singleton full term birth
- •birth weight 2500 to 4500g
- •Apgar (any) = 7
- •Age 0 to 28 days
- •exclusively breast-fed (breastfed reference arm) or formula-fed (formula-fed arms) at enrolment and for at least 90 days thereafter
- •informed consent from parents/legal guardians
排除标准
- •adverse maternal, foetal or Infant medical history with effects on growth or feeding tolerance
- •maternal gestational diabetes
- •allergy to cow´s milk proteins or increased risk of allergy
- •rehospitalisation within 5 days of birth
- •use of medication that affects gastrointestinal tolerance (incl. antibiotic therapy)
- •participation in another clinical trial
- •intention to use mixed feeding
- •investigators uncertainty about the willingness or ability of the parents to comply with the protocol requirements
研究者
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