Status:
COMPLETED
Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis
Lead Sponsor:
Universidad Peruana Cayetano Heredia
Conditions:
Sepsis
Eligibility:
All Genders
24-72 years
Phase:
PHASE2
Brief Summary
We will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. We will conduct a randomized placebo-controlled double blind study in 190 premature ...
Detailed Description
Lactoferrin is an iron chelating protein with multiple physiological functions (anti-microbial, anti-inflammatory and immunomodulatory) and is one of the most important proteins present in mammalian m...
Eligibility Criteria
Inclusion
- Neonates with a birth weight between 500g and 2500g
- Neonates born in, or referred to the Neonatal Intermediate and Intensive Care Units of one of the participating hospitals in the first 72 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 that, according to the investigator criteria, will not have the chance to complete the subsequent study visits (patients that before one month old would not be living in Lima).
- Neonates whose parents decline to participate.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT01264536
Start Date
December 1 2010
End Date
December 1 2011
Last Update
September 10 2012
Active Locations (3)
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1
Hospital Guillermo Almnara Irigoyen
Lima, Lima Province, Peru, Lima13
2
Hospital Nacional Cayetano Heredia
Lima, Lima Province, Peru, Lima31
3
Hospital Nacional Alberto Sabogal Sologuren
Callao, Lima, Peru, Callao2