NCT04495738终止不适用
Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 168
- 试验地点
- 27
- 主要终点
- Incidence of respiratory infection between study groups
研究概览
简要总结
The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months 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
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is judged to be in good health as determined from participant's medical history
- •Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks
- •Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
- •If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
- •If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
- •If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age
- •If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage
- •Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study
- •Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age
- •Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
排除标准
- •An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
- •Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
- •Participant is in another study that has not been approved as a concomitant study
- •Participant has been treated with antibiotics prior to enrollment
研究组 & 干预措施
Control Feeding Group
Active Comparator
Ready to feed milk-based product
干预措施: Control Infant Formula (Other)
Control Feeding Group
Active Comparator
Ready to feed milk-based product
干预措施: Control Toddler Drink (Other)
Experimental Feeding Group
Experimental
Ready to feed milk-based product with oligosaccharides
干预措施: Experimental Infant Formula (Other)
Experimental Feeding Group
Experimental
Ready to feed milk-based product with oligosaccharides
干预措施: Experimental Toddler Drink (Other)
Human Milk (HM) Reference Group
Other
HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product
干预措施: Supplemental Formula for HM Group (Other)
Human Milk (HM) Reference Group
Other
HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product
干预措施: Toddler Drink for HM group (Other)
结局指标
主要结局
Incidence of respiratory infection between study groups
时间窗: Study Day 1 to 6 Months of Age
Adverse event reports
次要结局
- Infection morbidity between study groups(Study Day 1 to 24 Months of Age)
研究者
研究点 (27)
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