Status:
UNKNOWN
Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate
Lead Sponsor:
Mooselmokadem
Conditions:
Neonatal Sepsis
Eligibility:
All Genders
Up to 28 years
Phase:
EARLY_PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01821989
Start Date
June 1 2013
Last Update
May 12 2014
Active Locations (1)
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1
Ain Shams University
Cairo, Abassia, Egypt