The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Food intake
研究概览
简要总结
The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. Once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. It is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, exclusively formula-fed infants aged 1-6 months at enrollment;
- •parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week.
排除标准
- •born < 37 weeks;
- •birth weight < 2500g or > 4000g;
- •current weight < 10th percentile for age;
- •hospitalization > 72 hours following birth or any hospital admission since birth;
- •any health issue that could interfere with feeding and/or growth;
- •use of complementary foods;
- •inability or unwillingness to comply with study-related procedures.
结局指标
主要结局
Food intake
时间窗: 2 weeks
Rate of intake, volume of intake, duration of meal
次要结局
未报告次要终点
研究者
Paula Chandler-Laney, PhD
Assistant Professor
University of Alabama at Birmingham
