Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Time to reach 100kcal/kg/d of enteral nutrition
研究概览
简要总结
This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.
详细描述
A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 10 Days 至 40 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 34 weeks gestational age at birth
- •Birth weight within 800-1800 grams
- •Exclusively or mostly breastfed (greater than 80% if the feeding volume)
- •Tolerated enteral feedings of 60 ml/kg/d
- •Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment
- •Signed Informed Consent
排除标准
- •Small for gestational age
- •Infants currently receiving ventilation therapy
- •Major congenital malformations
- •Suspected or documented systemic or congenital infections
- •Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth
- •Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia
- •Suspected or documented maternal substance abuse
- •Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days
研究组 & 干预措施
Standard Fortification
receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study
干预措施: human milk fortifier (Dietary Supplement)
Adjustable fortification
encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN)
干预措施: human milk fortifier (Dietary Supplement)
结局指标
主要结局
Time to reach 100kcal/kg/d of enteral nutrition
时间窗: participants will be followed until discharge, an expected average of 2 weeks
Days to reach 100kcal/kg/d of enteral nutrition
The weight gain velocity during hospitalization
时间窗: participants will be followed until discharge, an expected average of 2 weeks
The weight gain velocity(g/kg/d)
次要结局
- metabolic indicators after enrollment, including BUN,prealbumin, albumin(participants will be followed until discharge, an expected average of 2 weeks)
- The protein and energy ratio of enteral nutrition each week after enrollment(participants will be followed until discharge, an expected average of 2 weeks)
- Time to reach 2000g of body weight(participants will be followed until discharge, an expected average of 2 weeks)
研究者
Danhua Wang
Professor
Peking Union Medical College Hospital