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Supplementation With Lactoferrin in Preterm Newborns

NCT01172236 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2020-03-26

No results posted yet for this study

Summary

The main objective of the study is to evaluate the antioxidant effect of lactoferrin and its ability to reduce free radicals related diseases in the newborn. This evaluation will be done through the assessment of neuro-developmental follow-up.

The secondary objective is to identify a panel of markers for assessing oxidative stress and for a correlation with the lactoferrin antioxidant effect.

Conditions

Interventions

DRUG

Lactoferrin

Experimental group: newborns (group A) will receive a daily dose of 100 mg of lactoferrin (Dicorfam® Elleffe 1''% 2C supplement containing lactoferrin) + standard therapy. Control group: newborns (group B) will receive only standard therapy and they will be used as controls.

DRUG

Lactoferrin

Experimental group: 650 newborns (group A) will receive a daily dose of 100 mg of lactoferrin (Dicorfam® Elleffe 1''% 2C supplement containing lactoferrin) + standard therapy.Control group: 650 newborns (group B) will receive only standard therapy and they will be used as controls.

Sponsors & Collaborators

  • University of Siena

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
23 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2013-01-31

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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 NCT01172236 on ClinicalTrials.gov