Clinical Trial: Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
Brief Summary: To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
Detailed Summary:
Aim1: To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
- Lactoferrin related adverse events and serious adverse events
- Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)
- Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin absorption and excretion.
- Examine lactoferrin levels in saliva, urine, plasma and stool
- Examine lactoferrin levels in maternal and human donor milk.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
Sponsor: University of Virginia
Current Primary Outcome: Definitely related study solution serious adverse event [ Time Frame: 30 days while receiving study solution ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of infants reaching 120 ml/kg of enteral feeds [ Time Frame: 30 days while receiving study solution ]Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution
- Number of days not receiving any feedings after lactoferrin administration [ Time Frame: 30 days while receiving study solution ]Number of days not receiving any feedings after lactoferrin administration begun
Original Secondary Outcome: Same as current
Information By: University of Virginia
Dates:
Date Received: March 18, 2016
Date Started: April 2016
Date Completion: March 2017
Last Updated: April 18, 2016
Last Verified: April 2016
