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Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Very Low Birth Weight Infants Clinical Trial

Official title:
Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02731092
Study type Interventional
Source University of Virginia
Contact David A Kaufman, MD
Phone 4349245428
Email dak4r@virginia.edu
Status Recruiting
Phase Phase 1
Start date April 2016
Completion date March 2017
View Details
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