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Human Milk-derived Fortification in Preterm Infants

NCT05228847 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-11-07

No results posted yet for this study

Summary

Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Multi-nutrient human milk fortifiers (HMFs) are designed to meet the macro and micro-nutrient needs of VLBW infants. HMFs differ by the origin of milk and by nutrient composition. Traditionally, bovine milk has been the main source of multi-nutrient HMFs.

Conditions

  • Postnatal Growth Restriction
  • Necrotizing Enterocolitis

Interventions

DIETARY_SUPPLEMENT

Human milk-derived HMF

Fortification with human milk-derived product

DIETARY_SUPPLEMENT

bovine milk-derived HMF

bovine milk-derived HMF

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Belal Alshaikh, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2024-04-30
Completion
2025-05-30

Countries

  • Canada

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 NCT05228847 on ClinicalTrials.gov