Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

NCT02731092 | Unknown Phase 1 DMC

• 1 other identifier: IRB-HSR 18130
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Very Low Birth Weight Infants

Keywords

lactoferrin; very low birth weight infants; preterm infants

Outcome Measures

Primary Outcomes (1)

• Definitely related study solution serious adverse event

  30 days while receiving study solution

Secondary Outcomes (2)

• Number of infants reaching 120 ml/kg of enteral feeds

  30 days while receiving study solution

• Number of days not receiving any feedings after lactoferrin administration

  30 days while receiving study solution

Study Arms (3)

Lactoferrin 100 mg/kg

EXPERIMENTAL

100 mg/kg enteral administration daily for 30 days

Dietary Supplement: Lactoferrin

Lactoferrin 200 mg/kg

EXPERIMENTAL

200 mg/kg enteral administration daily for 30 days

Dietary Supplement: Lactoferrin

Lactoferrin 300 mg/kg

EXPERIMENTAL

300 mg/kg enteral administration daily for 30 days

Dietary Supplement: Lactoferrin

Interventions

Lactoferrin DIETARY_SUPPLEMENT

Bovine Lactoferrin 100 mg/ml dissolved in sterile water

Also known as: Bioferrin® 2000

Lactoferrin 100 mg/kg; Lactoferrin 200 mg/kg; Lactoferrin 300 mg/kg

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \< 15 days of age and receiving enteral feedings
• \< 1500 grams birth weight
• \<37 weeks gestation

You may not qualify if:

• Congenital bowel obstruction ( esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
• Known necrotizing enterocolitis or bowel perforation

Sponsors & Collaborators

• University of Virginia: lead
• The Gerber Foundation: collaborator

Study Sites (2)

University of Virginia Neonatal Intensive Care Unit

Charlottesville, Virginia, 22908, United States

RECRUITING

University of Virginia HealthSystem

Charlottesville, Virginia, 22932, United States

RECRUITING

MeSH Terms

Interventions

Lactoferrin

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• David A Kaufman, MD

  University of Virginia School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Kaufman, MD

CONTACT

4349245428; dak4r@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 7, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)