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Lactoferrin for Prevention of Sepsis in Infants

NCT01525316 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2021-12-06

No results posted yet for this study

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 result of decreased infections, infants' growth and development improve after daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory properties. If successful, the use of lactoferrin as a protective protein could profoundly affect clinical care of neonates both in the developed and developing world.

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • Theresa J Ochoa, MD · Universidad Peruana Cayetano Heredia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01525316 on ClinicalTrials.gov