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临床试验/NCT01526018
NCT01526018终止不适用

The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paula Chandler-Laney, PhD

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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