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

NCT02216292 | Completed DMC

• 1 other identifier: PSDM001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• necrotizing enterocolitis

  birth to 40 weeks of gestation

• Gastric residuals

  birth to 7th day of life

• Frequency of stool

  birth until 14th day of life

• culture positive sepsis

  birth to 40th week of gestation

Other Outcomes (1)

• body weight

  birth to 40th week of gestation

Study Arms (2)

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

Control Group

Retrospective control group receiving no donor milk = control group from March 2011 - May 2012

Other: Control Group

Interventions

Control Group OTHER

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

Control Group

Preterm Single Donor Milk Group OTHER

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

Preterm Single Donor Milk Group

Eligibility Criteria

• Age: 1 Minute - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Infant, Premature, Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nadja Haiden, Prof.MD

  Medical University of Vienna, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assoc. Prof.

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 13, 2014
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

AU (1)