PILOT STUDY: LACTOFERRIN FOR NEONATAL SEPSIS PREVENTIO

Not Applicable

• Conditions: -P36; P36

• Registration Number: PER-053-10
• Lead Sponsor: BILL & MELINDA GATES FOUNDATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 208

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Number of confirmed episodes of late-onset sepsis in the first month of life<br><br>Measure:Number of confirmed episodes of late-onset sepsis<br>Timepoints:1 month<br>

Secondary Outcome Measures

Name	Time	Method
<br>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.<br><br>Measure:Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality<br>Timepoints:1 month<br>