Do Infants Fed With BabyNes™ System Grow in Agreement With the World Health Organization (WHO) Reference?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the change in weight-for-age z-score of the WHO Child Growth Standard
研究概览
简要总结
Our main research question is: Do infants fed with BabyNes Nutrition System grow in agreement with the WHO reference?
Our second question is: Do infants fed with BabyNes Nutrition System have a metabolic profile closer to breastfed infants?
In order to answer both questions an observational trial will be carried out for 12 months in order to measure weight and to calculate the weight for age z-scores according to the WHO reference.
A breastfeeding group will be used as reference for the metabolic parameters measured in blood of infants from Chinese background.
The effect of the Babynes formulas will be compared to the metabolic values obtained from this breast-feeding reference group.
详细描述
Design:
12 months-study, with a breastfeeding group for the comparison of metabolic values obtained from a Chinese Reference population.
Number of subjects:
In total, 120 subjects shall be enrolled. 80 subjects will be assigned in formula fed group and 40 subjects to breast feeding group. 20% dropouts are already considered for the sample size of 120.
Product(s) to be tested:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborns, whose mothers had a normal BMI before pregnancy and no diabetes Healthy newborn infant. Full term infant (≥ 37 weeks gestation and ≤ 42 weeks gestation). Birth weight ≥ 2500 g and ≤ 4500 g. Having obtained his/her signed legal representative's informed consent.
- •For BF group:
- •Exclusively breastfed since birth, the infant's mother agrees to exclusively breast feed her infant until at least to 4th month.
- •Baby is 3 months (3 months ± 7 days) at enrollment.
- •For FF group:
- •Infant from birth to 21 days of age at the time of enrollment (the 21st day included).
- •The infant's mother has voluntarily elected to exclusively formula feed her infant after enrolment.
排除标准
- •Congenital illness or malformation that may affect normal growth (especially immunodeficiency).
- •Newborn whose mother's BMI was abnormal (<18.5 or >23.9) at start of pregnancy. Newborn whose mother has diabetes of type-1 or type-2 or other metabolic disorders.
- •Newborn whose mother has a chronic infectious disease. Newborn whose parents / caregivers cannot be expected to comply with treatment. Newborn currently participating in another nutritional interventional clinical trial (except for vaccination studies).
结局指标
主要结局
the change in weight-for-age z-score of the WHO Child Growth Standard
时间窗: from birth to 4 months of age
次要结局
- the Insulin, C-peptide, IGF-1 leptin and ghrelin level(at 4 and 12 months)
- length and head circumference measures(birth, 1, 2, 4, 6, 9 12 months of age)
- Body composition: fat mass, lean mass(4 months and 6 months)