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

Medical University of Vienna logo

Medical University of Vienna

Status

Completed

Conditions

Infant, Premature, Diseases

Treatments

Other: Preterm Single Donor Milk Group
Other: Control Group

Study type

Observational

Funder types

Other

Identifiers

NCT02216292
PSDM001

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

1 minute to 1 year old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Preterm Single Donor Milk Group
Description:
The prospective study group = preterm single donor milk group (PSDM-Group) from June 2012 - April 2013
Treatment:
Other: Preterm Single Donor Milk Group
Control Group
Description:
Retrospective control group receiving no donor milk = control group from March 2011 - May 2012
Treatment:
Other: Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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