Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The days to reach full enteral feeding volume (140 ml/kg/day).
研究概览
简要总结
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
详细描述
Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.
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
- None
入排标准
- 年龄范围
- 2 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).
排除标准
- •Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.
- •Died or extended to die within 48 hours of life
研究组 & 干预措施
Fortification at 20 ml/kg/day feeding volume
Human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day.
干预措施: Human milk fortifiers (Dietary Supplement)
Fortification at 100 ml/kg/day feeding volume
human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day.
干预措施: Human milk fortifiers (Dietary Supplement)
结局指标
主要结局
The days to reach full enteral feeding volume (140 ml/kg/day).
时间窗: 4 - 6 weeks
次要结局
- Neonatal Outcomes(until 4 weeks of life)
- Neonatal Outcomes(Until full feeding volume)
- Neonatal Outcomes(until 36 weeks PMA)