Impact of Preterm Single Donor Milk on Enteral Feeding in Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to full enteral feeding
研究概览
简要总结
Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available. Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical University Vienna was to start with formula feedings within the first 6 hours of life of a premature infant and switch over to breastmilk as soon it was available. In June 2012 the investigators changed this feeding regimen and started to use single donor milk of mothers of preterm infants for the first hours and days of the preterm infants life. In a prospective observational study the investigators evaluated the impact of single donor milk from preterm infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data will be compared with a historical control group starting with preterm formula as source of enteral nutrition. The investigators hypothesize that starting enteral nutrition with single donor milk of mothers from preterm infants with shorten time to full enteral feedings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 1 Year(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •very low birth weight infants with a birthweight <1500g
- •Gestational Age <32 weeks
- •Informed consent
排除标准
- •major congenital malformations
- •systemic metabolic diseases
- •short bowl syndrome
- •gastrointestinal abnormalities
- •when preterm infant was transferred or discharged
结局指标
主要结局
Time to full enteral feeding
时间窗: birth up to 40 weeks of gestation
Full enteral feedings are defined as an enteral inane of 135-145ml/kg/d
次要结局
- Frequency of stool(birth until 14th day of life)
- culture positive sepsis(birth to 40th week of gestation)
- necrotizing enterocolitis(birth to 40 weeks of gestation)
- Gastric residuals(birth to 7th day of life)
研究者
Nadja Haiden,MD
MD, Assoc. Prof.
Medical University of Vienna
