A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 6
- 主要终点
- Weight gain per day from baseline (g/day)
研究概览
简要总结
This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.
Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.
Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.
Safety, growth and tolerance parameters will be followed and collected throughout the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 44 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese term infants ≤ 44 days
- •Birth weight within normal range
- •Head circumference within normal range
- •Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age
排除标准
- •The mothers of infants:
- •who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
- •known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;
- •Parents/Legally acceptable representatives/Caregivers of infants:
- •who are incapable to comply with study protocol
- •who have to be fed with a special diet other than standard cow's milk based infant formula;
- •known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
- •known or suspected to have an allergic condition towards cow's milk, soy or fish;
- •with any history of, or current participation in any other study involving investigational or marketed products.
结局指标
主要结局
Weight gain per day from baseline (g/day)
时间窗: at the age of 17 weeks
次要结局
- Increment per day from baseline on length (mm/day)(at the age of 17 weeks)
- Increment per day from baseline on mid-upper arm circumference (mm/day)(at the age of 17 weeks)
- Z-scores of anthropometric parameters from baseline on weight(from baseline until the age of 17 weeks)
- Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant.(at the age of 17 weeks)
- Increment per day from baseline on head circumference (mm/day)(at the age of 17 weeks)
- Z-scores of anthropometric parameters from baseline on length(from baseline until the age of 17 weeks)
- Z-scores of anthropometric parameters from baseline on head circumference(from baseline until the age of 17 weeks)
- Z-scores of anthropometric parameters from baseline on mid-upper arm circumference(from baseline until the age of 17 weeks)
- Effect on incidence, frequency and severity of (serious) adverse events(from baseline until the age of 17 weeks)
- Parent-reported occurrence of diarrhea(from baseline until the age of 17 weeks)
- Parent-reported severity of diarrhea(from baseline until the age of 17 weeks)
- Parent-reported occurrence of constipation(from baseline until the age of 17 weeks)
- Parent-reported severity of constipation(from baseline until the age of 17 weeks)