Lactoferrin Prophylaxis in VLBW and Regulator T-cells

Study Overview
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Brief Summary
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The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.

Official Title
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Oral Lactoferrin Prophylaxis to Prevent Sepsis and Necrotising Enterocolitis of Very Low Birth Weight Neonates in Neonatal Intensive Care Unit and Effect on T-regulatory Cells.

Conditions
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Late Onset Neonatal Sepsis, Necrotising Enterocolitis, Very Low Birth Weight Infants

Intervention / Treatment
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* Dietary Supplement: Lactoferrin (bovine origin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inborn infants Gestational age < 32 weeks Birth weight < 1500 g Parental consent Exclusion Criteria: Congenital abnormalities Severe perinatal asphyxia

Ages Eligible for Study
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Minimum Age: 15 Minutes
Maximum Age: 1 Day

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>In born VLBW infants with parental consent form signed will be given oral saline daily as placebo until discharge | Dietary Supplement: Lactoferrin (bovine origin)<br>* Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula<br>|
| Experimental: Lactoferrin<br>In born VLBW infants with parental consent form signed will be given oral bovine lactoferrin daily until discharge | Dietary Supplement: Lactoferrin (bovine origin)<br>* Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late onset sepsis | The effect of oral Lactoferrin prophylaxis on the number of culture proven sepsis attacks in very low birth weight infants during their hospitalization in neonatal intensive care unit. Sterile blood, urine and cerebrospinal fluid samples will be obtained in case of clinical symptoms of sepsis for culture. | from birth to discharge from NICU | 
| Necrotising enterocolitis | The effect of oral Lactoferrin prophylaxis on severe necrotising enterocolitis (NEC) (Bell's stage 2 and 3) in very low birth infants during the hospitalization period in Neonatal intensive care unit. In case of feeding intolerance, abdominal distention and findings of ileus with clinical deterioration, patient will be evaluated for thrombocytopenia, metabolic acidosis, hyponatremia, blood in stool and radiological findings of NEC. Staging will be performed with clinical, laboratory and radiological findings. | from birth to discharge from NICU | 
| Effect on T regulatory cells | FOXP3 expression on CD4+CD25+ T cells | at discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of lactoferrin in VLBW infants | the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals | during the oral use of lactoferrin | 
| duration of hospitalization | the effect of oral lactoferrin on the duration of hospitalization | from birth to discharge from neonatal intensive care unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VLBW, NEC, Late onset sepsis