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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
42
Fortification with human milk-derived product
bovine milk-derived HMF
Foothills Medical Centre
Calgary, Alberta, Canada
Average weight gain
Average weight gain measured as g/kg per day
Time frame: up to 3 weeks
Head circumference
Measurement of head circumference in centimeters
Time frame: Weekly for 8 weeks
Length
Measurement of length in centimeters
Time frame: Weekly for 8 weeks
Feed intolerance
Incidence of interruption in enteral feeding due to feed intolerance (vomiting or abdominal distension), unrelated to a clinical procedure, that lasted for ≥12 hours or a \>50% reduction in volume over the same time frame.
Time frame: 3 weeks
Electrolytes abnormalities
Incidence of any abnormality in one of the following electrolytes: sodium, potassium, calcium and phosphorus
Time frame: 3 weeks
Need for additional signal nutrient supplementation
Number of additions of single nutrient supplementation (include protein, fat and carbohydrate) in each group.
Time frame: 3 weeks
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