Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

University of Virginia

Status and phase: Unknown; Phase 1

Conditions: Very Low Birth Weight Infants

Treatments: Dietary Supplement: Lactoferrin

Study type: Interventional

Funder types: Other

Identifiers

NCT02731092

IRB-HSR 18130

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 14 days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Lactoferrin 100 mg/kg

Experimental group

Description:

100 mg/kg enteral administration daily for 30 days

Treatment:

Dietary Supplement: Lactoferrin

Lactoferrin 200 mg/kg

Experimental group

Description:

200 mg/kg enteral administration daily for 30 days

Treatment:

Dietary Supplement: Lactoferrin

Lactoferrin 300 mg/kg

Experimental group

Description:

300 mg/kg enteral administration daily for 30 days

Treatment:

Dietary Supplement: Lactoferrin