NCT02021058已完成不适用
Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
Société des Produits Nestlé (SPN)8 个研究点 分布在 4 个国家目标入组 259 人开始时间: 2013年12月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 259
- 试验地点
- 8
- 主要终点
- Changes from baseline to 14 days in fuss-cry behavior
研究概览
简要总结
Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance
详细描述
The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term infants, singleton, healthy at birth
- •Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
- •Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
- •Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
排除标准
- •Infants who are consuming any amount of supplemental human milk
- •Infants who are consuming weaning foods or beverages other than infant formula
- •Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
- •Infants who have a medical condition or history that could cause or contribute to feeding intolerance
- •Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
结局指标
主要结局
Changes from baseline to 14 days in fuss-cry behavior
时间窗: from baseline to 14 days
fuss-cry behavior per 24 hours
次要结局
- Change from baseline to 14 days in GI symptoms(from baseline to 14 days)
研究者
研究点 (8)
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