Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

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.

Inclusion Criteria:

• < 15 days of age and receiving enteral feedings
• < 1500 grams birth weight
• <37 weeks gestation

Exclusion Criteria:

• Congenital bowel obstruction ( esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
• Known necrotizing enterocolitis or bowel perforation