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Clinical Trials/NCT02216292
NCT02216292
Completed
Not Applicable

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

Medical University of Vienna1 site in 1 country300 target enrollmentJune 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Premature, Diseases
Sponsor
Medical University of Vienna
Enrollment
300
Locations
1
Primary Endpoint
Time to full enteral feeding
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
June 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nadja Haiden,MD

MD, Assoc. Prof.

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • very low birth weight infants with a birthweight \<1500g
  • Gestational Age \<32 weeks
  • Informed consent

Exclusion Criteria

  • major congenital malformations
  • systemic metabolic diseases
  • short bowl syndrome
  • gastrointestinal abnormalities
  • when preterm infant was transferred or discharged

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (1)

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