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Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate

NCT01821989 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2014-05-12

No results posted yet for this study

Summary

Hypothesis:

Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.

The aim of the study is to:

* Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.
* Compare two dose regiment of lactoferrin supplementation.
* Study effect of lactoferrin supplementation on serum iron stores.

It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital.

•Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.

•Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily.

•Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.

Conditions

  • Neonatal Sepsis

Interventions

DIETARY_SUPPLEMENT

Lactoferrin

dose of 100 mg/day

DIETARY_SUPPLEMENT

Lactoferrin

dose of 150 mg/kg/ twice daily

DIETARY_SUPPLEMENT

Placebo

in form of distilled water

Sponsors & Collaborators

  • Mooselmokadem

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-01-31

Countries

  • Egypt

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 NCT01821989 on ClinicalTrials.gov