Recruiting
Phase 1

Lactoferrin

Sponsor:

University of Virginia

Code:

NCT02731092

Conditions

Very Low Birth Weight Infants

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Lactoferrin

Study Details

Brief summary:

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

Conditions

Very Low Birth Weight Infants

Study ID

NCT02731092

Start date

Apr, 2016

Status verified date

Apr, 2016

Completion date

Mar, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lactoferrin 100 mg/kg

100 mg/kg enteral administration daily for 30 days

experimental: Lactoferrin 200 mg/kg

200 mg/kg enteral administration daily for 30 days

experimental: Lactoferrin 300 mg/kg

300 mg/kg enteral administration daily for 30 days

Interventions

Lactoferrin

Bovine Lactoferrin 100 mg/ml dissolved in sterile water

Primary outcome measure

  • Definitely related study solution serious adverse event [ Time Frame: 30 days while receiving study solution ]

Central Contacts and Locations

Central contacts

David A Kaufman, MD

4349245428dak4r@virginia.edu

Locations

University of Virginia Neonatal Intensive Care Unit

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

David Kaufman, MD

434-924-9114Dak4r@virginia.edu

Principal Investigator:

David Kaufman, MD

University of Virginia HealthSystem

Recruiting

Charlottesville, Virginia, United States, 22932

Contacts

David A Kaufman, MD

434-924-5428dak4r@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Apr 19, 2016

Last verified

Apr, 2016

Keywords

  • lactoferrin
  • very low birth weight infants
  • preterm infants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2016-04-19.