Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Weight Gain Velocity
研究概览
简要总结
The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.
详细描述
This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
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 11 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days)
- •Birth weight of ≥ 2,500 g and ≤ 4,500 g
- •Postnatal age ≤ 11 days at time of enrollment
- •Singleton
- •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, reporting of AEs, and urine collection)
- •Caregiver willing and able to sign IRB approved informed consent
排除标准
- •Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- •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
- •Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin)
- •Infant receiving prescription medication
- •Infant with a known history of cow's milk protein allergy, excluding lactose intolerance
- •Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development
- •Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder
- •Caregiver intent to feed non-study formula or solid food during the study
研究组 & 干预措施
New Organic Infant Formula
New organic infant formula for healthy term infants
干预措施: New Organic Infant Formula (Other)
Commercial Organic Infant Formula
Commercially available organic infant formula for healthy term infants
干预措施: Commercial Organic Infant Formula (Other)
Breastfed Reference Group
Breastmilk
结局指标
主要结局
Weight Gain Velocity
时间窗: Study Day 1 to Study Day 112
Weight Gain Velocity (g/day)
次要结局
- Length(Study Day 1 to Study Day 112)
- Head Circumference(Study Day 1 to Study Day 112)
- Formula Intake(Study Day 1 to Study Day 112)
- Formula Intake (2)(Study Day 1 to Study Day 112)
- Anthropometry Z-scores(Study Day 1 to Study Day 112)