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临床试验/NCT02759809
NCT02759809已完成不适用

Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 1-Impact of Donor Milk at Kindergarten

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2016年6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
158
试验地点
1
主要终点
Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)

研究概览

简要总结

In Canada, the leading cause of long-term disability in children is being born at very low birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement of donor milk or preterm formula as not enough mother's milk is available. As the ideal supplement for prolonged feeding and its long-term effects is currently unknown, this study is a prospective follow up of VLBW infants who in hospital were fed: donor milk or preterm formula and/or mother's milk. Areas of development to be assessed include: cognition, language, motor skills, brain structure/function, and body composition. A DNA biorepository will also be created.

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
5 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who were enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).

排除标准

  • 未提供

结局指标

主要结局

Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)

时间窗: 5.5 years of age

次要结局

  • General Language Composite on the WPPSI-IV(5.5 years of age)
  • Verbal IQ on the WPPSI-IV(5.5 years of age)
  • Performance IQ on the WPPSI-IV(5.5 years of age)
  • Processing Speed Quotient on the WPPSI-IV(5.5 years of age)
  • Growth(5.5 years of age)
  • Body Composition(5.5 years of age)

研究者

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

Deborah O'Connor

Senior Associate Scientist, Research Institute

The Hospital for Sick Children

研究点 (1)

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