Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

April 18, 2016 updated by: David A Kaufman, University of Virginia
To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22932
        • Recruiting
        • University of Virginia HealthSystem
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Neonatal Intensive Care Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactoferrin 100 mg/kg
100 mg/kg enteral administration daily for 30 days
Dietary supplement: Lactoferrin
Bovine Lactoferrin 100 mg/ml dissolved in sterile water
Other Names:
  • Bioferrin® 2000
Experimental: Lactoferrin 200 mg/kg
200 mg/kg enteral administration daily for 30 days
Dietary supplement: Lactoferrin
Bovine Lactoferrin 100 mg/ml dissolved in sterile water
Other Names:
  • Bioferrin® 2000
Experimental: Lactoferrin 300 mg/kg
300 mg/kg enteral administration daily for 30 days
Dietary supplement: Lactoferrin
Bovine Lactoferrin 100 mg/ml dissolved in sterile water
Other Names:
  • Bioferrin® 2000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Definitely related study solution serious adverse event
Time Frame: 30 days while receiving study solution
30 days while receiving study solution

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days 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
30 days while receiving study solution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

The Gerber Foundation

Investigators

  • Principal Investigator: David A Kaufman, MD, University Of Virginia School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-HSR 18130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At UVA and MTA with outside institutions

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Very Low Birth Weight Infants

Clinical Trials on Lactoferrin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe