NCT03276663已完成不适用
Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study
Société des Produits Nestlé (SPN)12 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2017年9月18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
- 194
- 试验地点
- 12
- 主要终点
- Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months
研究概览
简要总结
Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.
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 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having obtained his/her parents' (or his/her legally accepted representative's [LAR's]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
- •Age ≤ 14 days after birth (date of birth = Day 0).
- •Full-term gestational birth (≥ 37 and ≤ 42 weeks).
- •Weight at birth ≥ 2500 g and ≤ 4200 g
- •Born to mothers with (normal) pre-pregnancy BMI ≥ 18.5 to < 26 kg/m
- •For formula-fed infants: born to mothers who independently elected, before study enrollment, not to breastfeed, but having received any HM is permitted (not applicable for infants in the HM-fed group)
- •For HM-fed infants: mothers intend to provide breast milk until age 6 months
- •Infant's parent(s)/LAR is of legal age of consent, has sufficient command of the French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol.
- •Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study.
排除标准
- •Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria).
- •Born to mothers who smoked > 10 cigarettes per day during pregnancy.
- •Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (> 3 alcoholic beverages per week) during pregnancy.
- •Cognitive or physical developmental disorders (e.g., malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader Willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders).
- •Participation in any other clinical trial prior to enrollment.
- •Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.
结局指标
主要结局
Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months
时间窗: 6 month
compared to the WHO reference standards or to the human milk (HM)-fed comparator group.
次要结局
未报告次要终点
研究者
研究点 (12)
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