Very Low Birth Weight Infants Clinical Trial
Official title:
Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
Aim1: To evaluate the safety and tolerability of three different lactoferrin doses in
preterm infants
1. Lactoferrin related adverse events and serious adverse events
2. Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)
3. Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin absorption and excretion.
1. Examine lactoferrin levels in saliva, urine, plasma and stool
2. Examine lactoferrin levels in maternal and human donor milk.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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