Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate
Study Details
Study Description
Brief Summary
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:
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Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Low Dose Lactoferrin,dose of 100 mg/day. |
Dietary Supplement: Lactoferrin
dose of 100 mg/day
|
| Experimental: High Dose Lactoferrin, dose of 150 mg/kg/ twice daily. |
Dietary Supplement: Lactoferrin
dose of 150 mg/kg/ twice daily
|
| Placebo Comparator: Control Receive placebo in form of distilled water. |
Dietary Supplement: Placebo
in form of distilled water
|
Outcome Measures
Primary Outcome Measures
- Blood culture [2 years]
Secondary Outcome Measures
- Complete blood count with differential leucocytic count. [2 years]
Other Outcome Measures
- C reactive protein quantitative assay [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Neonates with a birth weight between 500g and 2500g.
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Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period.
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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.
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Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
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Neonates with a family background of cow milk allergy.
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Neonates who will not have the chance to complete the study time (who will be referred to another hospitals).
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Neonates whose parents decline to participate.
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Neonates with early onset sepsis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ain Shams University | Cairo | Abassia | Egypt |
Sponsors and Collaborators
- Mooselmokadem
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- moos80