A Randomised, Controlled, Double-blind Trial to Investigate the Effects of a New Infant Formula in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 541
- 试验地点
- 4
- 主要终点
- Weight gain per day
研究概览
简要总结
This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.
详细描述
This is a "best after breast design" to measure the effect of this new infant formula in healthy term subjects on growth, body composition, tolerance and safety including immune status, gut microbiota, and early indicators (markers) of disease. These markers will be explored if they could predict the risk of eczema and other allergic disease, and to evaluate if these markers are influenced by early nutrition.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks)
- •Age ≤ 28 days
- •Birth weight within normal range for gestational age and sex (3rd to 90th percentile according to applicable growth charts)
- •Head circumference at birth within normal range (3rd to 90th percentile of the chart)
- •Chinese, Malay, or Indian ethnicity
- •Written informed consent from parent(s)
- •Currently reside in Singapore and with the intention to reside in Singapore for at least the next 2 years
- •Exclusion criteria for the pregnant women/parents:
- •Pregnant women / mothers who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation.
- •Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV)
- •Pregnant women / mothers known to have other significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (including, but not limited to: placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement
- •Incapability of the parents to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
- •Exclusion criteria for the subjects:
- •Infants known to have current or previous illnesses/ conditions or intervention which could interfere with the study (growth), as per investigator's clinical judgement
- •Infants with known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
- •Infants who need to be fed with a special diet other than a standard cow's milk-based infant formula
- •Infants who received any other infant formula, except the infant formula given in between birth and the initial breast-feeding (maximum of 3 consecutive days)
- •Infants with any history of or current participation in any other study involving investigational or marketed products.
排除标准
- 未提供
结局指标
主要结局
Weight gain per day
时间窗: 17 weeks
Weight gain per day from randomisation until 17 weeks of age.
Sum of skin fold thicknesses
时间窗: 24 months
Sum of skin fold thicknesses: triceps, biceps, suprailiac, subscapular until 24 months of age in subjects receiving the test product 1, test product 2, or control product.
Total weight gain
时间窗: 12 months
Total weight gain from birth until 12 months of age
次要结局
- Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold(24 months)
- Recumbent length, head circumference, mid-upper arm circumference, skin folds(17 weeks)
- Skin-fold thickness(12 months)