Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Head circumference.
研究概览
简要总结
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.
详细描述
A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. 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
- 1 Day 至 14 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 ≤ 14 days.
- •Singleton.
- •Designated as healthy, that is no recognized diseases.
- •Weight, length, weight-for-length, and head circumference within ≥ 5th and ≤ 95th percentile for age-sex according to World Health Organization (WHO) growth standards (birth to 24 months).
- •Exclusive feeding and tolerating cow milk formula at time of enrollment.
- •Parent(s) or legal guardians are willing and able to feed the assigned formula as sole source of nutrition.
- •Parent(s) or legal guardians are willing and able to participate in anthropometric procedures.
- •Parent(s) or legal guardians have voluntarily signed and dated required participation forms, such as the ICF approved by an IRB.
排除标准
- •An infant from a multiple birth, such as twin, triplet, or the like.
- •Personal or immediate family history of cow-milk protein allergy or intolerance.
- •Currently on any medication to treat growth failure or that may significantly impact growth.
- •Evidence of any anatomic and/or physiologic condition that would interfere with normal growth, development, or feeding, such as genetic, neurological, gastrointestinal, cardiac, pulmonary, hepatic, or renal.
- •A maternal history with known adverse effects on the fetus and/or the newborn infant, such as positive HIV, insulin-dependent diabetes, opioid exposure during pregnancy.
- •Enrolled in another clinical trial involving a drug, nutrition supplement, device, or intervention.
结局指标
主要结局
Head circumference.
时间窗: Study Day 1 to Study Day 112
Head circumference. Head circumference gain velocity. cm and cm/day
Anthropometry Z-scores.
时间窗: Study Day 1 to Study Day 112
Weight for age Z-score. Length for age Z-score. Weight for length Z-score. Head circumference for age Z-score.
Formula intake.
时间窗: Study Day 1 to Study Day 112
Volume of formula consumed. ml/day
Length.
时间窗: Study Day 1 to Study Day 112
Length. Length gain velocity. cm and cm/day.
Weight.
时间窗: Study Day 1 to Study Day 112
Weight. Weight gain velocity. g and g/day
次要结局
- Gastrointestinal characteristic.(Study Day 1 to Study Day 112)
- Formula tolerance.(Study Day 1 to Study Day 112)