Neonatal Sepsis Clinical Trial
Official title:
Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention
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