Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02731092

Enrollment

Registered

2016-04-07

Start date

2016-04-30

Completion date

2017-03-31

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Low Birth Weight Infants

Keywords

lactoferrin, very low birth weight infants, preterm infants

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 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.

Interventions

DIETARY_SUPPLEMENTLactoferrin

Bovine Lactoferrin 100 mg/ml dissolved in sterile water

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Days

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

Design outcomes

Primary

Measure	Time frame
Definitely related study solution serious adverse event	30 days while receiving study solution

Secondary

Measure	Time frame	Description
Number of infants reaching 120 ml/kg of enteral feeds	30 days while receiving study solution	Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution
Number of days not receiving any feedings after lactoferrin administration	30 days while receiving study solution	Number of days not receiving any feedings after lactoferrin administration begun

Countries

United States

Contacts

Primary ContactDavid A Kaufman, MD

dak4r@virginia.edu4349245428

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026