NCT02911454已完成不适用
Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations
Nutricia Research16 个研究点 分布在 3 个国家目标入组 252 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 16
- 主要终点
- Stool consistency measured by Amsterdam Stool Scale.
研究概览
简要总结
A prospective, multi-country, open label study to describe the stool characteristics and behaviour as well as the parents' experience in infants receiving a recently launched infant formula in a real life situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy term infants, gestational age up to and including 37 weeks and 42 weeks and below. Healthy is defined as "no supervision or medical treatment by a medical specialist. Further more to be determined by HCP.
- •Birth weight between 2.5 - 4.5 KG (within normal range for gestational age and sex)
- •Infants up to 6 weeks of postnatal age (Including day 42)
- •Receiving exclusively or at least 1 complete infant formula feeding per day at study inclusion (retrospectively exclusively or partly formula fed)
- •Willingness to change from their regular infant formula to study product
- •Parents' or legal guardians' aged up to and including 18 years, written, informed consent.
排除标准
- •Infants with a congenital condition and / or previous or current illness and (or) medication that could interfere with the study
- •Infants with established or suspected cows milk allergy, lactose intolerance, galactosaemia or infants on a prescribed fibre free (e.g. prebiotic oligosaccharides) diet
- •Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
- •Investigator's uncertainty about the willingness of the parents / legal guardians to comply with the protocol requirements.
研究组 & 干预措施
Healthy infants: fully or partly formula fed
Experimental
干预措施: Infant formula (Other)
结局指标
主要结局
Stool consistency measured by Amsterdam Stool Scale.
时间窗: 15 months
Will be reported in diaries completed by the parents.
Crying time
时间窗: 15 months
Will be reported in diaries completed by the parents.
Stool frequency
时间窗: 15 months
Will be reported in diaries completed by the parents.
次要结局
- Impact on family life(15 months)
- Eating behaviour(15 months)
- Parental experience of child behaviour(15 months)
研究者
研究点 (16)
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