NCT05508750已完成不适用
A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula
Jovie USA, LLC1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2022年9月21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
- 420
- 试验地点
- 1
- 主要终点
- Weight gain from baseline to 16 weeks feeding
研究概览
简要总结
The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal term infant (37-42 weeks gestation at birth)
- •Infant <15 (+3) days of age at first study feeding, Birth constitutes day 0
- •Infant birth weight of ≥2500 g (5.5 lbs.)
- •Healthy Infant
- •Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
- •Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs)
- •Caregiver willing and able to sign informed consent
排除标准
- •Infant born in multiple birth (i.e., twins, triplets, etc.)
- •Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- •Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
- •Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
- •Caregiver intent to feed non-study formula or solid food during the study
结局指标
主要结局
Weight gain from baseline to 16 weeks feeding
时间窗: 16 weeks
Weight gain g/day
次要结局
- Length gain from baseline to 16 weeks feeding(16 weeks)
- Head Circumference gain from baseline to 16 weeks feeding(16 weeks)
- Volume of formula consumed during 3-consecutive day intervals(16 weeks)
研究者
研究点 (1)
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