Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®

Prolacta Compare. Growth and Weight Gain in Extremely Low Birth Weight Infants Fed an Exclusively Human Milk Based Diet With Prolacta®

Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth.

Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. With this study, the investigators want to evaluate the effect of human milk fortification on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine fortification.

Study Overview

• Status: Completed
• Conditions: Preterm Infants; Weight Gain; Human Milk; Extremely Low Birth Weight
• Intervention / Treatment: Dietary supplement: Human milk fortifier based on human milk (Prolacta)

Detailed Description

Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. Many positive short-term health effects like prevention necrotizing enterocolitis , effects on gut development and immunological issues are associated with breast milk feedings.

The composition of breast milk usually meets the nutritional demands of term infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth and proper neurodevelopmental outcome.

Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. This human milk fortifier contains more energy and protein than bovine milk fortifiers. So far, accurate data on growth and weight gain under an exclusive diet with human milk and the human milk fortifier Prolact+6H2MF®are missing. With this study, the investigators want to evaluate the impact of a human milk based fortifier on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine milk based fortifier.

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Paracelsus Medical University
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ELBW infants (extremely low birth weight infants, <1000g birth weight)

Description

Inclusion Criteria:

• Preterm infants with a birth weight <1000 g

Exclusion Criteria:

• Congenital heart disease
• Major congenital birth defects
• Major inborn error of metabolism

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prolacta group; Infants, who received a human milk fortifier based on human milk (12/2015-11/2018), started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity	Dietary supplement: Human milk fortifier based on human milk (Prolacta); Intervention is started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity, afterwards a human milk fortifier based on bovine milk is administered until estimated date of birth or 52 weeks corrected for prematurity (weight <10. percentile) according to ESPGHAN(=European Society for paediatric gastroenterology, hepatology and nutrition) guidelines
"Frauenmilch Supplement"=FMS group; Infants, who received a human milk fortifier based on bovine milk (05/2012-06/2015), started with an enteral intake of 100 ml/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
growth velocity g/kg/d at 37+0 weeks	weight gain in g/kg/d	at 37+0 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
growth velocity g/kg/d at 32+0 weeks	weight gain in g/kg/d	at 32+0 weeks of gestation
growth velocity g/kg/d from start of fortification to 32+0 weeks	weight gain in g/kg/d	at 32+0 weeks of gestation
Weight at 32+0	weight in grams	at 32 weeks of gestation
Weight at 37+0	weight in grams	at 37+0 weeks of gestation
Length at 32+0	Length in cm	at 32+0 weeks of gestation
Length gain at 32+0	Length gain in cm/week	at 32+0 weeks of gestation
Head circumference at 32+0	head circumference in cm	at 32+0 weeks of gestation
Head circumference gain at 32+0	head circumference gain in cm/week	at 32+0 weeks of gestation
Length at 37+0	Length in cm	at 37 weeks of gestation
Lengthgain at 37+0	Lengthgain in cm/week	at 37 weeks of gestation
Head circumference at 37+0	Head circumference in cm	at 37 weeks of gestation
Head circumference gain at 37+0	Head circumference gain in cm/week	at 37 weeks of gestation
Time to full enteral feeds	Day of life when full enteral feeds (140ml/kg) are tolerated	up to 37 weeks of gestation
Incidence of necrotising enterocolitis	Necrotizing enterocolitis stage 2a according to Bell	up to 37 weeks of gestation
Body composition	Fat and Fat- free mass measured by Body plethysmography	up to 6 months corrected for prematurity
Blood parameter total protein	laboratory parameter	up to 37 weeks of gestation
Blood parameter Urea	laboratory parameter	up to 37 weeks of gestation
Blood parameter Triglyceride	laboratory parameter	up to 37 weeks of gestation
Blood parameter Glucose	laboratory parameter	up to 37 weeks of gestation
z- scores	z-scores for weight , length and head circumference	at 37 weeks of gestation

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Paracelsus Medical University
• Investigators: Principal Investigator: Assoc. Prof. PD. Nadja Haiden, MD, MSc, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Preterm infants; Infant weight gain; Human milk fortifier; ELBW infants
• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Birth Weight; Weight Gain
• Other Study ID Numbers: Prolacta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No