Status:
UNKNOWN
Human Milk-derived Fortification in Preterm Infants
Lead Sponsor:
University of Calgary
Conditions:
Postnatal Growth Restriction
Necrotizing Enterocolitis
Eligibility:
All Genders
3-12 years
Phase:
NA
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 lo...
Detailed Description
Recent advances in lacto-engineering techniques allowed the manufacturing of multi-nutrient HMF from human milk as an alternative to bovine milk. Since exposure to infant bovine-based formula feeds is...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05228847
Start Date
January 15 2023
End Date
May 30 2025
Last Update
November 7 2022
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9