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
1 other identifier
interventional
42
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedStudy Start
First participant enrolled
January 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedNovember 7, 2022
November 1, 2022
1.3 years
January 14, 2022
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average weight gain
Average weight gain measured as g/kg per day
up to 3 weeks
Secondary Outcomes (5)
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
Study Arms (2)
Human milk-derived HMF
ACTIVE COMPARATORFortification with human milk-derived product
Bovine milk-derived HMF
OTHERCurrent standard practice: Fortification with bovine milk-derived product
Interventions
Fortification with human milk-derived product
Eligibility Criteria
You may qualify if:
- Birthweight between 400 g-1250 g
- Less than or 32 weeks gestational age at birth
- Subject has been classified as appropriate for gestational age
- Enteral feeding of human milk is initiated by 72 hours
- Subject is expected to be on human milk for at least 3 weeks.
You may not qualify if:
- Congenital abnormalities or underlying disease that may affect growth
- Maternal cocaine, alcohol, or opioid abuse during pregnancy
- Mother or infant is currently receiving treatment for HIV infection
- Infant with major surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Foothills Medical Centre
Calgary, Alberta, T2N2T9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Belal Alshaikh, MD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor, Department of Pediatrics
Study Record Dates
First Submitted
January 14, 2022
First Posted
February 8, 2022
Study Start
January 15, 2023
Primary Completion
April 30, 2024
Study Completion
May 30, 2025
Last Updated
November 7, 2022
Record last verified: 2022-11