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Human Milk Fortification With Adjustable Versus Targeted Method

NCT04809350 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-11-30

No results posted yet for this study

Summary

Research question: Do preterm infants born \<1250 g achieve better weight gain with targeted fortification compared with the adjustable fortification of human milk?

Hypothesis: Targeted fortification of human milk results in better weight gain in infants with birth weight \<1250 gr when compared to the adjustable fortification.

Study design: Open-label, pragmatic, parallel randomized controlled trial in appropriate for gestational age infants with birth weight \<1250 g.

Conditions

  • Growth Failure

Interventions

DIETARY_SUPPLEMENT

Adjustable Human Milk Fortification

BUN and sodium concentrations will be measured every week in infants on full enteral feeds with fortified human milk. Liquid protein will be added based on serum urea.

DIETARY_SUPPLEMENT

Targeted Human Milk Fortification

Human milk will be analyzed twice weekly. Before the day of analysis, each mother will store fresh milk pumped from 10:00 AM until 8:00 AM of the previous day in a refrigerator and bring it to the hospital. Protein, fat, and sodium supplementation will be added to the human milk to meet the recommended daily intakes.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Belal Alshaikh, MD, MSc · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2024-05-31
Completion
2025-05-31

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 NCT04809350 on ClinicalTrials.gov