None listed
Conditions
Interventions
Group 1 Type of group
Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 4 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.
Group name:Group 2 Type of group
Infants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 4 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.
Sponsors
BILL & MELINDA GATES FOUNDATION,
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: • 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 criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Number of confirmed episodes of late-onset sepsis in the first month of life Measure:Number of confirmed episodes of late-onset sepsis Timepoints:1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality in the first month of life. Measure:Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality Timepoints:1 month | — |
Countries
Peru
Contacts
Public ContactALONSO PEZO SALAZAR
UNIVERSIDAD PERUANA CAYETANO HEREDIA
Outcome results
None listed