NCT05757323已完成不适用
A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
FrieslandCampina6 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2021年8月6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
- 345
- 试验地点
- 6
- 主要终点
- weight gain
研究概览
简要总结
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.
详细描述
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full-term infants (born at gestational age =37 weeks).
- •Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
- •Boys and girls
- •Apparently healthy at birth and screening
- •Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2)
- •Age at enrolment: =28 days of age
- •Exclusively formula fed for at least 5 days prior to inclusion
- •Exclusively formula fed during the entire intervention period
- •Parents agreeing to initiate complementary feeding after finalization of the study
- •Being available for follow up until the age of approximately 3.5 months
- •Written informed consent from parent(s) and/or legal guardian(s) aged =18 years
排除标准
- •Gestational age <37 weeks
- •Birth weight <2500 g or >4200 g
- •Age at enrolment: >28 days
- •Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
- •Illness at screening/inclusion
- •Incapability of parents to comply with the study protocol
- •Illiterate parents (i.e. not able to read and write in local language)
- •Participation in another clinical trial
- •Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
- •infants fed a special diet other than standard, non-hydrolysed, cow's or goat's milk based infant formula
结局指标
主要结局
weight gain
时间窗: until 17 weeks of age
weight gain in g/day
次要结局
- WAZ(until 17 weeks of age)
- head circumference-for-age Z-score(until 17 weeks of age)
- Weight(until 17 weeks of age)
- head circumference(until 17 weeks of age)
- BMI(until 17 weeks of age)
- LAZ(until 17 weeks of age)
- BMI-for-age Z-score(until 17 weeks of age)
- Length(until 17 weeks of age)
- WHZ(until 17 weeks of age)
研究者
研究点 (6)
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