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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02216292
Enrollment
300
Registered
2014-08-13
Start date
2012-06-30
Completion date
2014-06-30
Last updated
2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Premature, Diseases

Keywords

preterm single donor milk, human milk, very lo birth weight infants, enteral feedings, NEC

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.

Interventions

OTHERControl Group

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

OTHERPreterm Single Donor Milk Group

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

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 1 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to full enteral feedingbirth up to 40 weeks of gestationFull enteral feedings are defined as an enteral inane of 135-145ml/kg/d

Secondary

MeasureTime frameDescription
Frequency of stoolbirth until 14th day of lifeNumber of stools per day
culture positive sepsisbirth to 40th week of gestation
necrotizing enterocolitisbirth to 40 weeks of gestationNecrotising enterocolitis (NEC) was defined according to the stages by Bell as proven NEC grade 2a.
Gastric residualsbirth to 7th day of lifeGastric 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)

Other

MeasureTime frameDescription
body weightbirth to 40th week of gestationbody weight in gram is measured every second day.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026