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临床试验/NCT02073071
NCT02073071已完成不适用

Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants

Abbott Nutrition10 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
10
主要终点
Weight

研究概览

简要总结

This is a two stage open-label, single-arm, multicenter and observational study.

详细描述

Stage 1: In hospital, preterm/low birth weight infants less than or equal to 34 weeks gestational age at birth, birth weight of ≥ 1000g to <1800g and conditions meeting the enrollment criteria will be fed formula with or without parenteral nutrition until discharge. Stage 2: Post-discharge, all infants with birth weight < or =1500g will be followed on formula per standard of care and accepted standard of care including feeding until the infant's weight >or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.

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
— 至 21 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Weight

时间窗: Change from first feeding to discharge (up to ~8 weeks)

次要结局

  • Length(Change from first feeding to discharge (up to ~8 weeks))
  • Head Circumference(Change from first feeding to discharge (up to ~8 weeks))
  • Hospitalization Length of Stay(Time from Birth to discharge (up to ~8 weeks))
  • Gastrointestinal Tolerance(From first feeding to discharge (up to ~8 weeks))
  • Catch Up Growth(From discharge to 9 months corrected age)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (10)

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