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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infant, Premature, Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm Single Donor Milk Group

The prospective study group = preterm single donor milk group (PSDM-Group) from June 2012 - April 2013

Preterm Single Donor Milk Group

Intervention Type OTHER

Infants received preterm single donor milk during their first days of life until breastmilk from their own mother was available

Control Group

Retrospective control group receiving no donor milk = control group from March 2011 - May 2012

Control Group

Intervention Type OTHER

Infants received preterm formula during their first days of life until breastmilk from their own mother was available

Interventions

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Control Group

Infants received preterm formula during their first days of life until breastmilk from their own mother was available

Intervention Type OTHER

Preterm Single Donor Milk Group

Infants received preterm single donor milk during their first days of life until breastmilk from their own mother was available

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No