A Randomized Study of the Use of Human Milk Cream as a Caloric Supplement in a Subset of Very Low Birth Weight Pre-Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Caloric content of human milk
研究概览
简要总结
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.
详细描述
Once fortification (to either mother's or donor milk) is initiated and tolerance is established (based on clinical observation), infants will be randomized into one of two groups: to receive human milk cream or not.
- Human Milk Cream Group: Human milk (either mother's own or donor) will be tested (once per container of milk). If the caloric level falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz.
- Control Group (no human milk cream): Milk (either mother's own or donor) and human milk fortifier will be provided as usual (milk will be analyzed for study purposes).
This nutritional algorithm will continue until the infant reaches 36 weeks corrected gestational age/weaned from fortifier (whichever comes first) or is otherwise removed from the study (due to transfer to non-study institution, removal from the study or death).
Data will be collected from the time of study entry until the infant reaches 36 weeks corrected gestational age or weaned from the fortifier (whichever comes first) or is otherwise removed from the study.
Primary measure of efficacy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight 750 - 1250g
- •Able to adhere to expected feeding protocol of mother's own milk/donor milk with fortification of Prolacta® fortifier
- •Reasonable expectation of survival
- •Enteral feeding must begin before the 21st day of life
排除标准
- •Decision to not start minimum enteral feed before day 21 of life
- •Unable to obtain informed consent from parent/guardian prior to the initiation of fortification of enteral feeding
- •Enrolled in any other clinical study affecting nutritional management during the study period
- •Presence of clinically significant congenital heart disease or major congenital malformations
- •Reasonable potential for early transfer to a non-study institution
研究组 & 干预措施
Human Milk Cream Group
For infants randomized to the human milk cream group, the human milk (either mother's own or donor) being provided to the infant will be tested each time a new container is used to prepare feedings. The test will be for the caloric content of the milk using a commercially available device provided for this purpose. If the caloric level falls below 20 kcal/oz for any test, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. The amount added will be calculated to the nearest mL rounding down for 0.1-0.4mL and up for 0.5-0.9 mL to avoid imprecision due to the measuring device used in the nutrition preparation area.
干预措施: Human Milk Cream (Dietary Supplement)
Control Group
For infants randomized to the Control group, human milk and human milk derived fortifier will be provided according to the institutional standard of care and there will be no use of the milk analysis (mother's own or donor), which is typical for the vast majority of neonatal intensive care units.
结局指标
主要结局
Caloric content of human milk
时间窗: Daily until 36 weeks corrected gestational age
Human milk samples will be analyzed for macronutrients and total caloric content.
次要结局
- Growth(Weekly until 36 weeks corrected age)
研究者
Amy Hair
Assistant Professor of Pediatrics
Baylor College of Medicine