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临床试验/NCT02216292
NCT02216292已完成不适用

Impact of Preterm Single Donor Milk on Enteral Feeding in Very Low Birth Weight Infants

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadja Haiden,MD

MD, Assoc. Prof.

Medical University of Vienna

研究点 (1)

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