Necrotizing Enterocolitis, Postnatal Growth Restriction
Conditions
Keywords
Human milk
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.
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).
Interventions
DIETARY_SUPPLEMENTHuman milk-derived HMF
Fortification with human milk-derived product
DIETARY_SUPPLEMENTbovine milk-derived HMF
bovine milk-derived HMF
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Days to 12 Weeks
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average weight gain | up to 3 weeks | Average weight gain measured as g/kg per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head circumference | Weekly for 8 weeks | Measurement of head circumference in centimeters |
| Length | Weekly for 8 weeks | Measurement of length in centimeters |
| Feed intolerance | 3 weeks | 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. |
| Electrolytes abnormalities | 3 weeks | Incidence of any abnormality in one of the following electrolytes: sodium, potassium, calcium and phosphorus |
| Need for additional signal nutrient supplementation | 3 weeks | Number of additions of single nutrient supplementation (include protein, fat and carbohydrate) in each group. |
Countries
Canada
Contacts
Primary ContactBelal Alshaikh, MD, MSc
Outcome results
None listed