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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human milk-derived HMF | Active Comparator | Fortification with human milk-derived product |
|
| Bovine milk-derived HMF | Other | Current standard practice: Fortification with bovine milk-derived product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human milk-derived HMF | Dietary Supplement | Fortification with human milk-derived product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average weight gain | Average weight gain measured as g/kg per day | up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Head circumference | Measurement of head circumference in centimeters | Weekly for 8 weeks |
| Length | Measurement of length in centimeters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Belal Alshaikh, MD, MSc | Contact | 4039561588 | balshaik@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Belal Alshaikh, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N2T9 | Canada |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| bovine milk-derived HMF | Dietary Supplement | bovine milk-derived HMF |
|
| 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. | 3 weeks |
| Electrolytes abnormalities | Incidence of any abnormality in one of the following electrolytes: sodium, potassium, calcium and phosphorus | 3 weeks |
| Need for additional signal nutrient supplementation | Number of additions of single nutrient supplementation (include protein, fat and carbohydrate) in each group. | 3 weeks |
| D007410 |
| Intestinal Diseases |