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

Completed

• Conditions: Infant, Premature, Diseases
• Interventions: Other: Preterm Single Donor Milk Group; Other: Control Group

• Registration Number: NCT02216292
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-04
• Study Completion: 2014-06
• Status Verified: 2014-08
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-11
• Last Update Submitted: 2014-08-11
• Study First Posted: 2014-08-13
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to full enteral feeding	birth up to 40 weeks of gestation	Full enteral feedings are defined as an enteral inane of 135-145ml/kg/d

Secondary Outcome Measures

Name	Time	Method
Frequency of stool	birth until 14th day of life	Number of stools per day
culture positive sepsis	birth to 40th week of gestation
necrotizing enterocolitis	birth to 40 weeks of gestation	Necrotising enterocolitis (NEC) was defined according to the stages by Bell as proven NEC grade 2a.
Gastric residuals	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)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria