Clinical Trial: Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: Time to full enteral feeding [ Time Frame: birth up to 40 weeks of gestation ]

Full enteral feedings are defined as an enteral inane of 135-145ml/kg/d


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • necrotizing enterocolitis [ Time Frame: birth to 40 weeks of gestation ]
    Necrotising enterocolitis (NEC) was defined according to the stages by Bell as proven NEC grade 2a.
  • Gastric residuals [ Time Frame: birth to 7th day of life ]
    Gastric residuals are a parameter for gastrointestinal tolerance and are determined every three hours before the next meal is given and are aspirated via a gastric tube Gastric residuals are measured in ml/kg per meal. Furthermore the color is documented (milky, clear, mucous, bile stained, bloody)
  • Frequency of stool [ Time Frame: birth until 14th day of life ]
    Number of stools per day
  • culture positive sepsis [ Time Frame: birth to 40th week of gestation ]


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: August 11, 2014
Date Started: June 2012
Date Completion:
Last Updated: August 11, 2014
Last Verified: August 2014