Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants

Detailed Description
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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.

Official Title
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Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Conditions
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Very Low Birth Weight Infants

Intervention / Treatment
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* Dietary Supplement: Lactoferrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoferrin 100 mg/kg<br>100 mg/kg enteral administration daily for 30 days | Dietary Supplement: Lactoferrin<br>* Bovine Lactoferrin 100 mg/ml dissolved in sterile water<br>* Other names: Bioferrin® 2000;|
| Experimental: Lactoferrin 200 mg/kg<br>200 mg/kg enteral administration daily for 30 days | Dietary Supplement: Lactoferrin<br>* Bovine Lactoferrin 100 mg/ml dissolved in sterile water<br>* Other names: Bioferrin® 2000;|
| Experimental: Lactoferrin 300 mg/kg<br>300 mg/kg enteral administration daily for 30 days | Dietary Supplement: Lactoferrin<br>* Bovine Lactoferrin 100 mg/ml dissolved in sterile water<br>* Other names: Bioferrin® 2000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definitely related study solution serious adverse event |  | 30 days while receiving study solution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infants reaching 120 ml/kg of enteral feeds | Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution | 30 days 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 | 30 days while receiving study solution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactoferrin, very low birth weight infants, preterm infants