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

August 11, 2014 updated by: Nadja Haiden,MD, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

inborn very low birth weight infants with a birthweight <1500g and a gestational age <32 weeks

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preterm Single Donor Milk Group
The prospective study group = preterm single donor milk group (PSDM-Group) from June 2012 - April 2013
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
Control Group
Retrospective control group receiving no donor milk = control group from March 2011 - May 2012
Other: Control Group
Infants received preterm formula during their first days of life until breastmilk from their own mother was available

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
birth up to 40 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
birth to 40 weeks of gestation
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)
birth to 7th day of life
Frequency of stool
Time Frame: birth until 14th day of life
Number of stools per day
birth until 14th day of life
culture positive sepsis
Time Frame: birth to 40th week of gestation
birth to 40th week of gestation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight
Time Frame: birth to 40th week of gestation
body weight in gram is measured every second day.
birth to 40th week of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Nadja Haiden, Prof.MD, Medical University of Vienna, Department of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSDM001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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