Status:
COMPLETED
Lactoferrin for Prevention of Sepsis in Infants
Lead Sponsor:
Universidad Peruana Cayetano Heredia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Late Onset Neonatal Sepsis
Eligibility:
All Genders
1-72 years
Phase:
PHASE3
Brief Summary
The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a resul...
Detailed Description
Neonatal mortality is an important global public health challenge. Approximately 4 million neonatal deaths per year occur in developing countries, accounting for 40% all of deaths in children under 5....
Eligibility Criteria
Inclusion
- Neonates with a birth weight between 500g and 2000g
- 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 who have a family history 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 :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT01525316
Start Date
May 1 2012
End Date
October 1 2016
Last Update
December 6 2021
Active Locations (3)
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1
Hospital Nacional Alberto Sabogal Sologuren
Lima, Peru, 0511
2
Hospital Nacional Cayetano Heredia
Lima, Peru, 0511
3
Hospital Nacional Guillermo Almenara Irigoyen
Lima, Peru, 0511