NCT02646969已完成不适用
Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Société des Produits Nestlé (SPN)18 个研究点 分布在 1 个国家目标入组 691 人开始时间: 2015年10月1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
- 691
- 试验地点
- 18
- 主要终点
- Growth velocity of formula regimen 1 and 2 versus WHO growth curve
研究概览
简要总结
Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life
详细描述
The overall objective of this study is to assess growth and biomarkers of energy and protein metabolism in healthy term infants fed with two different study formula regimens from birth to 12 months of age and to follow up the infants to 4 years of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants will be enrolled in the study provided they meet the following inclusion criteria:
- •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 ≤ 7 days after birth (date of birth = Day 0)
- •Full-term gestational birth (≥ 37 and ≤ 42 weeks)
- •Born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and < 26 kg/m2
- •Born to mothers who independently elected, before study enrollment, not to breastfeed (not applicable for infants in the HM-fed comparator group)
- •Weight ≥ 2'500 g and ≤ 4'200 g
- •Infant's parent(s)/LAR is of legal age of consent, has sufficient command of 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
- •Infants who exhibit one or more of the following criteria are excluded from enrollment in the study:
- •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)
- •Received radiation therapy (eg. scannography or interventional radiology)
- •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 of formula regimen 1 and 2 versus WHO growth curve
时间窗: 0-6 months
Compare weight gain velocity (g/day) of each formula-fed group from enrollment to 6 months of age and compare to the World Health Organization (WHO) standards
Growth velocity (g/day) of formula regimen 1 and 2 versus a human milk (HM)-fed comparator group
时间窗: 0-6 months
Assess the growth velocity of each formula-fed group from enrollment to 6 months of age and compare to growth velocity of a human milk (HM)-fed comparator group.
次要结局
- Body Composition: Fat free mass density [kg/L] using PeaPod(1-6 months)
- Assess the adverse events (AEs) among all study subjects(0-4 years)
- Body Composition: Fat free mass [kg] using PeaPod(1-6 months)
- Body Composition: Percentage fat mass using PeaPod(1-6 months)
- Growth velocity of formula regimen 1 and 2 versus WHO growth curve and versus a human milk (HM)-fed comparator group(0-3 months and 0-12 months)
- Other growth parameters z-scores of formula regimen 1 and 2 versus WHO standards and versus a human milk (HM)-fed comparator group(6 and 12 months)
- Body Composition: Body mass [kg] using PeaPod(1-6 months)
- Assess and compare the child behavior in each group until 4 years of age(0-4 years)
- Body Composition: Percentage fat free mass using PeaPod(1-6 months)
- Assess and compare the neurodevelopment in each group until 4 years of age(0-4 years)
- Body Composition: Body surface area [cm²] using PeaPod(1-6 months)
- Body Composition: Body volume [L] using PeaPod(1-6 months)
- Body Composition: Fat Free Mass [g] using DEXA(0-3 years)
- Compare metabolic biomarkers measures in each formula-fed group to the HM-fed group(0-4 years)
- Body Composition: Body density [kg/L] using PeaPod(1-6 months)
- Body Composition: Bone Mineral Density [g/cm²] using DEXA(0-3 years)
- Body Composition: Total mass [g] using DEXA(0-3 years)
- Body Composition: Fat mass [kg] using PeaPod(1-6 months)
- Body Composition: Thoracic gas volume (L) using PeaPod(1-6 months)
- Body Composition: Bone area [cm²] using DEXA(0-3 years)
- Body Composition: Lean mass [g] using DEXA(0-3 years)
- Stool microbiota profile, and metabolomics endpoints in each group. Associations between microbiota and metabolomics profiles (serum, urine, and stool).(0-4 years)
- Body Composition: Bone Mineral Content [g] using DEXA(0-3 years)
- Body Composition: Fat mass [g] using DEXA(0-3 years)
- Body Composition: Percentage fat using DEXA(0-3 years)
研究者
研究点 (18)
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