NCT02401217已完成不适用
Tolerance of Healthy Infants Fed Infant Formulas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 12
- 主要终点
- Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries
研究概览
简要总结
The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Singleton from a full term birth with a gestational age of 37-42 weeks.
- •Birth weight was > 2490 g (~5 lbs 8 oz).
- •Age between 0 and 30 days at enrollment.
- •Agreement to discontinue the use of medications (including over the counter [OTC], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
- •Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
- •Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
- •Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) 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 infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Infant treated with antibiotics.
- •Participation in another study that has not been approved as a concomitant study by AN.
结局指标
主要结局
Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries
时间窗: Change from Study Day 1 to Study Day 15
MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard.
次要结局
- Mean predominant stool consistency and color measured using parent reported diaries(Change from Study Day 1 to Study Day 15)
- Average number of stools per day measured using parent reported diaries(Change from Study Day 1 to Study Day 15)
- Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire.(Change from Study Day 1 to Study Day 15)
- Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.(Change from Study Day 1 to Study Day 15)
- Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires(Change from Study Day 1 to Study Day 15)
- Mean Percentage of stools representing each stool consistency and color using parent reported diaries(Change from Study Day 1 to Study Day 15)
研究者
研究点 (12)
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