Prolacta Compare. Growth and Weight Gain in Extremely Low Birth Weight Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- growth velocity g/kg/d at 37+0 weeks
研究概览
简要总结
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth.
Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. With this study, the investigators want to evaluate the effect of human milk fortification on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine fortification.
详细描述
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. Many positive short-term health effects like prevention necrotizing enterocolitis , effects on gut development and immunological issues are associated with breast milk feedings.
The composition of breast milk usually meets the nutritional demands of term infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth and proper neurodevelopmental outcome.
Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. This human milk fortifier contains more energy and protein than bovine milk fortifiers. So far, accurate data on growth and weight gain under an exclusive diet with human milk and the human milk fortifier Prolact+6H2MF®are missing. With this study, the investigators want to evaluate the impact of a human milk based fortifier on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine milk based fortifier.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with a birth weight <1000 g
排除标准
- •Congenital heart disease
- •Major congenital birth defects
- •Major inborn error of metabolism
结局指标
主要结局
growth velocity g/kg/d at 37+0 weeks
时间窗: at 37+0 weeks of gestation
weight gain in g/kg/d
次要结局
- growth velocity g/kg/d at 32+0 weeks(at 32+0 weeks of gestation)
- Weight at 37+0(at 37+0 weeks of gestation)
- Length at 32+0(at 32+0 weeks of gestation)
- Length gain at 32+0(at 32+0 weeks of gestation)
- Time to full enteral feeds(up to 37 weeks of gestation)
- Incidence of necrotising enterocolitis(up to 37 weeks of gestation)
- growth velocity g/kg/d from start of fortification to 32+0 weeks(at 32+0 weeks of gestation)
- Weight at 32+0(at 32 weeks of gestation)
- Head circumference gain at 32+0(at 32+0 weeks of gestation)
- Length at 37+0(at 37 weeks of gestation)
- Blood parameter total protein(up to 37 weeks of gestation)
- Head circumference at 32+0(at 32+0 weeks of gestation)
- Lengthgain at 37+0(at 37 weeks of gestation)
- Head circumference at 37+0(at 37 weeks of gestation)
- Head circumference gain at 37+0(at 37 weeks of gestation)
- Body composition(up to 6 months corrected for prematurity)
- Blood parameter Urea(up to 37 weeks of gestation)
- Blood parameter Triglyceride(up to 37 weeks of gestation)
- Blood parameter Glucose(up to 37 weeks of gestation)
- z- scores(at 37 weeks of gestation)
研究者
Nadja Haiden,MD
Associate Professor for Pediatrics
Medical University of Vienna