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Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Primary Purpose

Very Low Birth Weight Infants

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lactoferrin

About this trial

This is an interventional treatment trial for Very Low Birth Weight Infants focused on measuring lactoferrin, very low birth weight infants, preterm infants

Eligibility Criteria

undefined - 14 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Virginia Neonatal Intensive Care UnitRecruiting
University of Virginia HealthSystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Lactoferrin 100 mg/kg

Lactoferrin 200 mg/kg

Lactoferrin 300 mg/kg

Arm Description

100 mg/kg enteral administration daily for 30 days

200 mg/kg enteral administration daily for 30 days

300 mg/kg enteral administration daily for 30 days

Outcomes

Primary Outcome Measures

Definitely related study solution serious adverse event

Secondary Outcome Measures

Number of infants reaching 120 ml/kg of enteral feeds

Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution

Number of days not receiving any feedings after lactoferrin administration

Number of days not receiving any feedings after lactoferrin administration begun

Full Information

NCT ID

NCT02731092

First Posted

March 18, 2016

Last Updated

April 18, 2016

Sponsor

University of Virginia

Collaborators

The Gerber Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02731092

Brief Title

Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Official Title

Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

The Gerber Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 Lactoferrin related adverse events and serious adverse events Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day) Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated Aim 2: To evaluate lactoferrin absorption and excretion. Examine lactoferrin levels in saliva, urine, plasma and stool Examine lactoferrin levels in maternal and human donor milk. Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Very Low Birth Weight Infants

Keywords

lactoferrin, very low birth weight infants, preterm infants

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactoferrin 100 mg/kg

Arm Type

Experimental

Arm Description

100 mg/kg enteral administration daily for 30 days

Arm Title

Lactoferrin 200 mg/kg

Arm Type

Experimental

Arm Description

200 mg/kg enteral administration daily for 30 days

Arm Title

Lactoferrin 300 mg/kg

Arm Type

Experimental

Arm Description

300 mg/kg enteral administration daily for 30 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactoferrin

Other Intervention Name(s)

Bioferrin® 2000

Intervention Description

Bovine Lactoferrin 100 mg/ml dissolved in sterile water

Primary Outcome Measure Information:

Title

Definitely related study solution serious adverse event

Time Frame

30 days while receiving study solution

Secondary Outcome Measure Information:

Title

Number of infants reaching 120 ml/kg of enteral feeds

Description

Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution

Time Frame

30 days while receiving study solution

Title

Number of days not receiving any feedings after lactoferrin administration

Description

Number of days not receiving any feedings after lactoferrin administration begun

Time Frame

30 days while receiving study solution

10. Eligibility

Sex

All

Maximum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David A Kaufman, MD

Phone

4349245428

dak4r@virginia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A Kaufman, MD

Organizational Affiliation

University of Virginia School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia Neonatal Intensive Care Unit

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Kaufman, MD

Phone

434-924-9114

Dak4r@virginia.edu

First Name & Middle Initial & Last Name & Degree

David Kaufman, MD

Facility Name

University of Virginia HealthSystem

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22932

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David A Kaufman, MD

Phone

434-924-5428

dak4r@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

At UVA and MTA with outside institutions

Learn more about this trial

Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

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