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

Study Overview
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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.

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

Conditions
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Infant, Premature, Diseases

Intervention / Treatment
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* Other: Control Group
* Other: Preterm Single Donor Milk Group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to full enteral feeding | 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 | Necrotising enterocolitis (NEC) was defined according to the stages by Bell as proven NEC grade 2a. | birth to 40 weeks of gestation | 
| Gastric residuals | 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 | Number of stools per day | birth until 14th day of life | 
| culture positive sepsis |  | birth to 40th week of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm single donor milk, human milk, very lo birth weight infants, enteral feedings, NEC