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

Infant, Premature, Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216292
• Other study ID #: PSDM001
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: August 11, 2014
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Weight
• Infant, Premature, Diseases

Intervention

Other:
• Control Group
Infants received preterm formula during their first days of life until breastmilk from their own mother was available
• 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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	body weight	body weight in gram is measured every second day.	birth to 40th week of gestation	No
Primary	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	No
Secondary	necrotizing enterocolitis	Necrotising enterocolitis (NEC) was defined according to the stages by Bell as proven NEC grade 2a.	birth to 40 weeks of gestation	No
Secondary	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	Yes
Secondary	Frequency of stool	Number of stools per day	birth until 14th day of life	No
Secondary	culture positive sepsis		birth to 40th week of gestation	Yes