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

NCT03886844 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 196

Last updated 2019-04-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Paracelsus Medical University

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Assoc. Prof. PD. Nadja Haiden, MD, MSc · Medical University of Vienna

Eligibility

Min Age
1 Day
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03886844 on ClinicalTrials.gov