Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- growth during first three weeks of intervention
研究概览
简要总结
The proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial. The combination of additional fat, carbohydrate and protein and commercial fortifier will be added to ensure that the milk contains the target amounts of nutrient. Growth and development of these infants will be compared with that of infants fed mother's milk that has been supplemented with the current standard amounts. The postnatal growth of the infants will be assessed by measuring weight, length and head circumference and fat and lean mass using highly accurate, non-invasive methods throughout the intervention period and at the first follow-up visit after discharge at 3 months. Neurological development will be analyzed at the age of 18 months.
The investigators hypothesize that individualized fortification of breast milk improves the nutritional intake of preterm infants, optimizing growth, and thus this will positively impact neurodevelopment and health.
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 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
growth during first three weeks of intervention
时间窗: first three weeks during intervention before 36 weeks of gestation
change in body weight gain will be accessed daily.
次要结局
- weight gain(from inclusion at postmentrual age <32 weeks until 18 month corrected age)
- head circumference(from inclusion at postmentrual age <32 weeks until 18 month corrected age)
- neurodevelopment(at 18 month corrected age)
- body length(from inclusion at postmentrual age <32 weeks until 18 month corrected age)
- body composition(from inclusion at postmentrual age <32 weeks until 3 month corrected age)
- feeding intolerance(during intervention (postmentrual age <32 weeks until 36 weeks))
- nutrient's blood parameter(during intervention (postmentrual age <32 weeks until 36 weeks))
- breast milk analysis(during intervention (postmentrual age <32 weeks until 36 weeks))
- enteral energy intake(from inclusion at postmentrual age <32 weeks until 36 weeks)
- skin fold thickness(from inclusion at postmentrual age <32 weeks until 18 month corrected age)
- body composition (bio-electrical impedance analysis)(from inclusion at postmentrual age <32 weeks until 18 month corrected age)
- morbidity(during intervention (postmentrual age <32 weeks until 36 weeks))
研究者
Christoph Fusch
Professor and Division Head
McMaster Children's Hospital