NCT01821989

Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate

Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Mooselmokadem · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Accepted

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: * 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.

Conditions

• Neonatal Sepsis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactoferrin	dose of 100 mg/day
DIETARY_SUPPLEMENT	Lactoferrin	dose of 150 mg/kg/ twice daily
DIETARY_SUPPLEMENT	Placebo	in form of distilled water

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-01-01
• First posted: 2013-04-01
• Last updated: 2014-05-12

Locations

1 site across 1 country: Egypt