NCT05228847

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 3 Days – 12 Weeks
• Healthy volunteers: Not accepted

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.

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 frequently shown to increase neonatal morbidities, human milk-derived HMFs (H-HMFs) have been frequently proposed to minimize exposure to bovine products prior to 34 weeks gestation with an intent to decrease the risks of necrotizing enterocolitis and feeding intolerance. The use of multi-nutrient H-HMFs is a promising intervention however currently available H-HMFs are expensive. The main objective of this randomized controlled trial is to compare the weight gain achieved by preterm infants born \<1250 g and fed human milk fortified with H-HMFs (made from mother's own milk (MOM) when MOM supply exceeds the daily need of her preterm infant or from donor human milk (DHM) compared with counterparts fed human milk fortified with the currently used bovine-derived fortifier (B-HMF).

Conditions

• Postnatal Growth Restriction
• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Human milk-derived HMF	Fortification with human milk-derived product
DIETARY_SUPPLEMENT	bovine milk-derived HMF	bovine milk-derived HMF

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-04-30
• Completion: 2025-05-30
• First posted: 2022-02-08
• Last updated: 2022-11-07

Locations

1 site across 1 country: Canada