Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 24
- 主要终点
- Infant stool consistency and frequency (assessed using a 3-day stool diary)
研究概览
简要总结
The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. Anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.
详细描述
Parents / legally acceptable representatives of eligible infants will be invited to volunteer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Days 至 49 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, term (37-42 weeks gestation), singleton infant at birth.
- •Post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry.
- •At enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts.
排除标准
- •Infants who are consuming any types/brands of formula other than the new study formula (either exclusively or in a mixed feeding regimen) at time of study enrollment.
- •Suspected or documented severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the infant inappropriate for entry into the study.
结局指标
主要结局
Infant stool consistency and frequency (assessed using a 3-day stool diary)
时间窗: day 45
次要结局
- Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)(day 48)
- Infant and parent health-related quality of life (assessed using validated parent questionnaires)(day 48)