An interventional study of Human milk-derived HMF and bovine milk-derived HMF in Postnatal Growth Restriction and Necrotizing Enterocolitis, sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 3 Days to 12 Weeks. Per ClinicalTrials.gov, last updated 2022-11-07.
Sponsored by University of Calgary · Not applicable, Interventional, and Supportive care
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).
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 42 is below the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fortification with human milk-derived product
Dietary Supplement: Human milk-derived HMF
Current standard practice: Fortification with bovine milk-derived product
Dietary Supplement: bovine milk-derived HMF
Fortification with human milk-derived product
bovine milk-derived HMF
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
Start is estimated for Jan 2023; primary completion for Apr 2024, 15 months later.
Of 33 interventional studies with no phase under Enterocolitis, Necrotizing, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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