Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Study Overview
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Brief Summary
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The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.

Detailed Description
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This study was carried out on 180 preterm neonates(< 37 weeks of gestation counting from the first day of the Last Menstrual Period and confirmed by Ballard score) admitted to the Neonatal Intensive Care Units of Ain Shams University Hospitals in the period from August 2014 to December 2015. Enrolled subjects were further randomly subdivided into three groups according to the dose regimen of Lactoferrin supplementation. Group A: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 1 and continue for 4-6 weeks. Group B: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 3 (48hrs-72hrs) of life and continue for 4-6 weeks. Group C: (60 preterm neonates) who match the subjected neonates, received placebo in form of distilled water.

Official Title
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Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Conditions
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Neonatal Sepsis

Intervention / Treatment
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* Drug: Lactoferrin
* Drug: Placebo (for Lactoferrin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates with a < 37 weeks of gestation counting from the first day of the Last Menstrual Period. Preterm neonates are breast fed, artificially fed or on total parenteral nutrition. Preterm neonates born in, or referred to our Neonatal Intensive Care Unit in the first day of life free from infection and not fed. 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 with early onset sepsis. Neonates whose parents decline to participate.

Ages Eligible for Study
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Maximum Age: 3 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Lactoferrin Group<br>Oral Bovine Lactoferrin 100 mg/day once starting on day 1 of life and continued for 4-6 weeks. | Drug: Lactoferrin<br> <br> * Other names: Bovine Lactoferrin;|
| Experimental: Late Lactoferrin Group<br>Oral Bovine Lactoferrin 100 mg/day once starting on day 3 of life and continued for 4-6 weeks. | Drug: Lactoferrin<br> <br> * Other names: Bovine Lactoferrin;|
| Active Comparator: Placebo Group<br>placebo in form of distilled water once starting on day 1 of life and continued for 4-6 weeks. | Drug: Placebo (for Lactoferrin)<br>* placebo in form of distilled water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture. |  | 4-6 weeks of life | 
| Compare early (1st day) versus late (48-72 hours) Lactoferrin administration on neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture |  | 4-6 weeks of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Lactoferrin supplementation on long term complications | Long term complications as: Broncho-Pulmonary Dysplasia using clinical symptoms and signs and chest X ray findings. Retinopathy of Prematurity using the International Classification of Retinopathy of Prematurity (ICROP). Necrotizing Enterocolitis using Modified Bell's criteria for staging Necrotizing Enterocolitis. | 4-6 weeks of life | 
| any reported side effects for Bovine Lactoferrin |  | 4-6 weeks of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Late onset sepsis, Bovine Lactoferrin