Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding
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
- 否
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
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
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
Tarah T Colaizy
Associate Professor of Pediatrics
University of Iowa
