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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02731092
• Other study ID #: IRB-HSR 18130
• Status: Recruiting
• Phase: Phase 1
• First received: March 18, 2016
• Last updated: April 18, 2016
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: University of Virginia
• Contact: David A Kaufman, MD
• Phone: 4349245428
• Email: dak4r[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Very Low Birth Weight Infants

Intervention

Dietary Supplement:
• Lactoferrin
Bovine Lactoferrin 100 mg/ml dissolved in sterile water

Locations

Country	Name	City	State
United States	University of Virginia HealthSystem	Charlottesville	Virginia
United States	University of Virginia Neonatal Intensive Care Unit	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Definitely related study solution serious adverse event		30 days while receiving study solution	Yes
Secondary	Number of infants reaching 120 ml/kg of enteral feeds	Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution	30 days while receiving study solution	No
Secondary	Number of days not receiving any feedings after lactoferrin administration	Number of days not receiving any feedings after lactoferrin administration begun	30 days while receiving study solution	No