What side effects are associated with this type of intervention?

Common treatments for Very Low Birthweight (VLBW) infants with antimicrobial, antioxidant, and anti-inflammatory properties include oral bovine lactoferrin, probiotics, and prebiotics. Oral bovine lactoferrin is generally well-tolerated, but potential side effects may include gastrointestinal discomfort. Probiotics, while beneficial for gut health, can rarely cause infections, particularly in immunocompromised infants. Prebiotics are usually safe but may lead to mild gastrointestinal symptoms such as bloating and gas. Overall, these treatments are considered safe with minimal adverse effects, but close monitoring is essential.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments similar to oral bovine lactoferrin for Very Low Birthweight (VLBW) infants in the provided context. Generally, treatments for VLBW infants focus on addressing complications such as infections, inflammation, and oxidative stress. Commonly used interventions include antibiotics for infections, antioxidants like vitamin E, and anti-inflammatory agents. The trial studying oral bovine lactoferrin aims to leverage its antimicrobial, antioxidant, and anti-inflammatory properties to reduce mortality and major morbidity in VLBW preterm infants.

What other types of research exist?

Promising alternatives to oral bovine lactoferrin for very low birthweight patients include probiotics like Lactobacillus reuteri, omega-3 fatty acids, and nutritional supplements such as Coenzyme Q10 and other antioxidants. These alternatives have shown potential antimicrobial, antioxidant, and anti-inflammatory properties in various studies.

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Dietary Supplement

Bovine Lactoferrin for Very Low Birth Weight in Premature Infants

Q: What is the mechanism of action of this treatment?

Very Low Birthweight (VLBW) infants are at high risk for infections and inflammatory conditions due to their underdeveloped immune systems. Treatments like oral bovine lactoferrin (bLF) are being studied for their antimicrobial, antioxidant, and anti-inflammatory properties. Lactoferrin works by binding to iron, which bacteria need to grow, thus inhibiting bacterial proliferation. Its antioxidant properties help neutralize free radicals, reducing oxidative stress, while its anti-inflammatory effects modulate the immune response to prevent excessive inflammation. These mechanisms are crucial for VLBW infants as they help reduce the incidence of sepsis and necrotizing enterocolitis, improving survival rates and long-term health outcomes.

Phase 3

Waitlist Available

Led By Elizabeth Asztalos, MD,MSc,FRCPC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infant must be <1500 g at birth

Infant must be 2-7 days old and not moribund

Must not have

Major congenital gastrointestinal anomalies preventing an early approach to feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to 36 weeks corrected gestation

Awards & highlights

Pivotal Trial

Summary

This trial uses a protein from cow's milk to help very small preterm babies. These babies are chosen because they often don't get enough natural protection from their mother's milk. The protein works by fighting infections, reducing inflammation, and protecting cells.

Who is the study for?

The LIFT_Canada trial is for very low birth weight preterm infants who are stable, between 2-7 days old, have started feeding, and weigh less than 1500 grams at birth. Infants with severe congenital anomalies or major gastrointestinal issues that affect feeding cannot participate.

What is being tested?

This study tests if adding bovine lactoferrin to the diets of premature babies can reduce death or serious illness by using its antimicrobial and anti-inflammatory effects. Babies in the trial will be randomly assigned to receive either bovine lactoferrin or no supplement.

What are the potential side effects?

As a natural protein found in milk, bovine lactoferrin is expected to be safe for infants. However, potential side effects may include allergic reactions or intolerance specific to individual babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby weighed less than 1500 grams at birth.

Select...

My baby is between 2-7 days old and not at risk of dying.

Select...

My infant has started feeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a major birth defect in my digestive system that affects feeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to 36 weeks corrected gestation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to 36 weeks corrected gestation

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to 36 weeks corrected gestation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital mortality or major morbidity

Secondary study objectives

Incidence of death by 24 months corrected age or the presence of neurodevelopmental outcomes at 24 months corrected age

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment1 Intervention

The intervention group will receive a daily dose of 200 mg/kg of bovine lactoferrin in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.

Group II: Control GroupPlacebo Group1 Intervention

The control group will receive daily study feed with no bovine lactoferrin added in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bovine Lactoferrin

2020

Completed Phase 3

~940

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Very Low Birthweight (VLBW) infants are at high risk for infections and inflammatory conditions due to their underdeveloped immune systems. Treatments like oral bovine lactoferrin (bLF) are being studied for their antimicrobial, antioxidant, and anti-inflammatory properties. Lactoferrin works by binding to iron, which bacteria need to grow, thus inhibiting bacterial proliferation. Its antioxidant properties help neutralize free radicals, reducing oxidative stress, while its anti-inflammatory effects modulate the immune response to prevent excessive inflammation. These mechanisms are crucial for VLBW infants as they help reduce the incidence of sepsis and necrotizing enterocolitis, improving survival rates and long-term health outcomes.

Oral lactoferrin for the prevention of sepsis and necrotizing enterocolitis in preterm infants.Oral lactoferrin for the prevention of sepsis and necrotizing enterocolitis in preterm infants.Oral lactoferrin for the treatment of sepsis and necrotizing enterocolitis in neonates.