NCT02731092

Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 14 Days
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants

Detailed description

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.

Conditions

• Very Low Birth Weight Infants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactoferrin	Bovine Lactoferrin 100 mg/ml dissolved in sterile water

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2016-04-07
• Last updated: 2016-04-19

Locations

2 sites across 1 country: United States