NCT05228847|Unknown
Human Milk-derived Fortification in Preterm Infants
Effect of Human Milk-derived Fortifiers on Weight Gain in Preterm Infants <1250 g: A Randomized Controlled Trial
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Effect of Human Milk-derived Fortifiers on Weight Gain in Preterm Infants <1250 g: A Randomized Controlled Trial
Sponsor study identifier
interventional
42
1 country
1
Study Start
January 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 14, 2022
Actual (reported)February 8, 2022
Actual (reported)January 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Average weight gain
Average weight gain measured as g/kg per day
up to 3 weeks
Head circumference
Weekly for 8 weeks
Length
Weekly for 8 weeks
Feed intolerance
3 weeks
Electrolytes abnormalities
3 weeks
Need for additional signal nutrient supplementation
3 weeks
Fortification with human milk-derived product
Current standard practice: Fortification with bovine milk-derived product
Fortification with human milk-derived product
bovine milk-derived HMF
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Foothills Medical Centre
Calgary, Alberta, T2N2T9, Canada
Belal Alshaikh, MD
University of Calgary
First Submitted
January 14, 2022
First Posted
February 8, 2022
Study Start
January 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 7, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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