Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate

Study Overview
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Brief Summary
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Hypothesis: Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants. The aim of the study is to: Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis. Compare two dose regiment of lactoferrin supplementation. Study effect of lactoferrin supplementation on serum iron stores. It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital. •Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day. •Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily. •Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.

Official Title
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Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.

Conditions
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Neonatal Sepsis

Intervention / Treatment
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* Dietary Supplement: Lactoferrin
* Dietary Supplement: Lactoferrin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates with a birth weight between 500g and 2500g. Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period. Preterm neonates born in, or referred to the Neonatal Intensive Care Units of one of the participating hospitals in the first 48 hours of life. Exclusion Criteria: Neonates with underlying gastrointestinal problems that prevent oral intake. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities). Neonates with a family background of cow milk allergy. Neonates who will not have the chance to complete the study time (who will be referred to another hospitals). Neonates whose parents decline to participate. Neonates with early onset sepsis.

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Dose<br>Lactoferrin,dose of 100 mg/day. | Dietary Supplement: Lactoferrin<br>* dose of 100 mg/day<br>|
| Experimental: High Dose<br>Lactoferrin, dose of 150 mg/kg/ twice daily. | Dietary Supplement: Lactoferrin<br>* dose of 150 mg/kg/ twice daily<br>|
| Placebo Comparator: Control<br>Receive placebo in form of distilled water. | Dietary Supplement: Placebo<br>* in form of distilled water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood culture |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete blood count with differential leucocytic count. |  | 2 years |