NCT04066413终止不适用
Growth and Tolerance Trial in Healthy Infants on Infant Formula Supplemented With a Human Milk Oligosaccharide
FrieslandCampina2 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2019年9月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Growth
研究概览
简要总结
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age ≥ 37 weeks
- •Birth weight ≥ 2500 grams
- •No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
- •Boys and girls
- •Recruited < 1 month/age
- •Being available for follow up until the age of 4 months
- •Exclusive formula feeding or exclusive breast feeding at time of recruitment
排除标准
- •Gestational age <37 weeks
- •Birth weight <2500 grams
- •Severe acquired or congenital diseases, mental or physical disorders
- •Illness at screening/ inclusion
- •Incapability of parents/caregivers to comply with the study protocol
- •Received antibiotics within the first month of life
- •Not tolerating standard cow's milk based infant formula
- •Participation in another clinical trial
- •Maternal illicit drug use during pregnancy or post-partum period
- •Parent/caregiver does not have a cell phone to use for filling out questionnaires
结局指标
主要结局
Growth
时间窗: From enrollment until end of the 3 month-study
Infant growth measured as body weight gain per day
次要结局
- Weight(Monthly, from enrollment until end of the 3 month-study)
- Head circumference(Monthly, from enrollment until end of the 3 month-study)
- Recumbent length(Monthly, from enrollment until end of the 3 month-study)
- Anthropometry z-scores(Monthly, from enrollment until end of the 3 month-study)
- Formula tolerance(Monthly, from enrollment until end of the 3 month-study)
- Gastro-intestinal comfort(Monthly, from enrollment until end of the 3 month-study)
研究者
研究点 (2)
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