Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Phase 1

• Conditions: Very Low Birth Weight Infants

• Registration Number: NCT02731092
• Lead Sponsor: University of Virginia

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-18
• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-07
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Definitely related study solution serious adverse event	30 days while receiving study solution

Secondary Outcome Measures

Name	Time	Method
Number of infants reaching 120 ml/kg of enteral feeds	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	30 days while receiving study solution	Number of days not receiving any feedings after lactoferrin administration begun

Trial Locations

Locations (2)

University of Virginia Neonatal Intensive Care Unit; 🇺🇸 Charlottesville, Virginia, United States

University of Virginia HealthSystem; 🇺🇸 Charlottesville, Virginia, United States