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临床试验/NCT01232725
NCT01232725已完成不适用

Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

Tarah T Colaizy2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2009年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
121
试验地点
2
主要终点
Cognitive scale score of the Bayley Scales of Infant Development, III

研究概览

简要总结

Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks for obesity, hypertension and other chronic diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW) preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not always available, and pasteurized donor human milk is an alternative that requires investigation. Whether donor milk conveys health and developmental advantages similar to those bestowed by maternal milk is unknown. By determining the effects of donor milk on health and developmental outcomes when compared to preterm infant formula, the investigators seek to optimize outcomes in this fragile population. The hypothesis of our donor milk research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm infant formula diet.

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 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • <1501 g weight at birth

排除标准

  • chromosomal anomalies
  • congenital heart disease
  • congenital disorders known to impair neurodevelopment

研究组 & 干预措施

Donor Human Milk

Experimental

VLBW infants randomized to be fed donor human milk, fortified as appropriate, for all feedings for which maternal milk is not available, including infants who receive no maternal milk

干预措施: Donor Human Milk (Dietary Supplement)

Preterm Formula

Experimental

VLBW infants randomized to receive preterm infant formula for any feedings for which maternal milk is unavailable, including infants receiving no maternal milk

干预措施: Donor Human Milk (Dietary Supplement)

结局指标

主要结局

Cognitive scale score of the Bayley Scales of Infant Development, III

时间窗: 18 - 22 months' adjusted age

We will administer the BSID III to all subjects at 18-22 mo of age, adjusted for prematurity. We will compare the scores between subjects who received donor human milk to those who received preterm infant formula

次要结局

  • Late Onset sepsis(4 months)
  • length of hospital stay(4 months)

研究者

发起方
Tarah T Colaizy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tarah T Colaizy

Associate Professor of Pediatrics

University of Iowa

研究点 (2)

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