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临床试验/NCT01699386
NCT01699386已完成3 期

Growth of Infants Fed an Elemental Medical Food

Abbott Nutrition4 个研究点 分布在 1 个国家目标入组 213 人开始时间: 1999年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
213
试验地点
4
主要终点
Weight

研究概览

简要总结

Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 9 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Singleton, healthy infant
  • Gestational age of 37 to 42 weeks
  • Birth weight of 2500 grams or greater
  • Age between birth and 9 days of age
  • Parents agree to not administer mineral or vitamin supplements during the study period
  • Parents agree to feed study formula exclusively for the duration of the study

排除标准

  • Maternal, fetal or perinatal history which may have adverse effects on growth
  • Multiple birth

结局指标

主要结局

Weight

时间窗: 14 days of age to 112 days of age

weight gain during the study period

次要结局

  • Lab Measurement(At 112 day visit)
  • Anthropometric Measurements(14 days of age to 112 days of age)
  • GI Tolerance(At visits 14 and 28)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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