NCT06256094已完成不适用
The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants
a2 Milk Company Ltd.1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2023年7月14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
- 280
- 试验地点
- 1
- 主要终点
- Body weight measured in gram.
研究概览
简要总结
This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy, term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The participants were randomly assigned to one of the two study groups: the a2 infant formula group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The study duration was 56 days.
详细描述
Primary objective:
To compare the growth measurements of the infants fed with the a2 infant formula with those fed with conventional A1/A2 infant formula during the study period.
Secondary objectives:
To compare the two study groups in
- Dermatitis quality of life
- Formula tolerability and acceptability
- All medically confirmed adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Days 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and term infants (37-42 weeks gestation);
- •Birth weight between 2500g and 4500g;
- •60-120 days of age after birth;
- •Mixed-fed: Infants who were fed with a mixture of formula and human milk, and received daily formula consumption of more than 400ml;
- •Signed informed consent obtained form the guardian(s) of the infants;
- •Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey.
排除标准
- •Congenital anomaly or hereditary/chronic/congenital diseases that could interfere with the study product evaluations;
- •Evidence of feeding difficulties or intolerance/allergy to cow's milk;
- •Conditions requiring infant feedings other than those specified in the protocol;
- •Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other) or parental refusal to participate;
- •Acute infection or gastroenteritis at the time of enrollment;
- •Participation in other clinical trials at the time of the study;
- •Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
结局指标
主要结局
Body weight measured in gram.
时间窗: Baseline, Day 14, Day 28, Day 56
Body weight measured in gram.
次要结局
- Body length measured in centimeter.(Baseline, Day 14, Day 28, Day 56)
- Length-for-age Z-score that describe the distance and direction of the body length of a participant away from the mean body length of the population of the same age(Baseline, Day 14, Day 28, Day 56)
- Weight-for-length Z-score that describe the distance and direction of the weight of a participant away from the mean weight of the population of the same body length(Baseline, Day 14, Day 28, Day 56)
- Head circumference measured in centimeter.(Baseline, Day 14, Day 28, Day 56)
- Body mass index calculated from body weight and length.(Baseline, Day 14, Day 28, Day 56)
- Weight-for-age Z-score that describe the distance and direction of the weight of a participant away from the mean of the population of the same age(Baseline, Day 14, Day 28, Day 56)
- BMI-for-age Z-score that describe the distance and direction of the body mass index of a participant away from the mean body mass index of the population of the same age(Baseline, Day 14, Day 28, Day 56)
- Head circumference-for-age Z-score that describe the distance and direction of the head circumference of a participant away from the mean head circumference of the population of the same age(Baseline, Day 14, Day 28, Day 56)
- Infants' gastrointestinal symptom score evaluated using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)(Baseline, Day 14, Day 28, Day 56)
- Average daily formula intake amount (ml/day) during the past week measured by formula intake diary(Baseline, Day 14, Day 28, Day 56)
- Percent of participants with relieved skin symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire(Day 56)
- Percent of parents of the participants with intention of continuing to feed the child with the study formula, measured in 3 levels: Yes, No, or Not sure using the Formula Satisfaction Questionnaire(Day 56)
- Number of crying periods evaluated in each 15-minutes period during a day(Baseline, Day 14, Day 28, Day 56)
- Infants' Dermatitis Quality of Life Index (IDQoL) that measured participants' quality of life related to dermatitis(Baseline, Day 14, Day 28, Day 56)
- Percent of participants with relieved gastrointestinal symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire(Day 56)
- Percent of overall satisfaction levels with the study formula, measured in 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure using the Formula Satisfaction Questionnaire(Day 56)
研究者
研究点 (1)
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