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

NCT03886844 | Completed

• 1 other identifier: Prolacta
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Weight Gain; Human Milk; Preterm Infants; Extremely Low Birth Weight

Keywords

Infant weight gain; Human milk fortifier; Preterm infants; ELBW infants

Outcome Measures

Primary Outcomes (1)

• growth velocity g/kg/d at 37+0 weeks

  weight gain in g/kg/d

  at 37+0 weeks of gestation

Secondary Outcomes (20)

• growth velocity g/kg/d at 32+0 weeks

  at 32+0 weeks of gestation

• growth velocity g/kg/d from start of fortification to 32+0 weeks

  at 32+0 weeks of gestation

• Weight at 32+0

  at 32 weeks of gestation

• Weight at 37+0

  at 37+0 weeks of gestation

• Length at 32+0

  at 32+0 weeks of gestation

Study Arms (2)

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)

"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

Interventions

Human milk fortifier based on human milk (Prolacta) DIETARY_SUPPLEMENT

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

Prolacta group

Eligibility Criteria

• Age: 1 Day - 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Preterm infants with a birth weight \<1000 g

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Paracelsus Medical University: collaborator

Study Sites (2)

Paracelsus Medical University

Salzburg, 5020, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Assoc. Prof. PD. Nadja Haiden, MD, MSc

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor for Pediatrics

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: December 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)