Lactoferrin for Prevention of Sepsis in Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

414

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Late Onset Neonatal Sepsis
Interventions
DIETARY_SUPPLEMENT

Bovine Lactoferrin

Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 8 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum lactoferrin concentration will be 25mg/mL.

DIETARY_SUPPLEMENT

Maltodextrin

Infants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 8 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum maltodextrin concentration will be 25mg/mL.

Trial Locations (3)

0511

Hospital Nacional Alberto Sabogal Sologuren, Lima

Hospital Nacional Cayetano Heredia, Lima

Hospital Nacional Guillermo Almenara Irigoyen, Lima

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Universidad Peruana Cayetano Heredia

OTHER

NCT01525316 - Lactoferrin for Prevention of Sepsis in Infants | Biotech Hunter | Biotech Hunter