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Supplementation With Lactoferrin in Preterm Newborns (lactoprenew)

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ClinicalTrials.gov Identifier: NCT01172236
Recruitment Status : Unknown
Verified April 2010 by University of Siena.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2010
Last Update Posted : July 29, 2010
Sponsor:
Information provided by:
University of Siena

Brief 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.


Condition or disease Intervention/treatment Phase
Prematurity Low Birth Weight Drug: Lactoferrin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supplementation With Lactoferrin in Preterm Newborns
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lactoferrin 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.



Primary Outcome Measures :
  1. 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 trough the assessment of neuro-developmental follow-up. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The secondary objective is to identify a panel of markers for assessing oxidative stress and for a correlation with the lactoferrin antioxidant effect. [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Newborns with a birthweight ≤ 1500 grand/or gestational age ≤ 32 weeks
  • Sign of the informed consent by parents

Exclusion criteria:

  • Fetal-onset disorders and/or recognizable at birth
  • Milk intolerance
  • Family history of allergies
  • Use of infant formula supplemented with lactoferrin

Responsible Party: Prof. Giuseppe Buonocore, University of Siena Italy
ClinicalTrials.gov Identifier: NCT01172236     History of Changes
Other Study ID Numbers: NEO-LF100-2010
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Lactoferrin
Anti-Infective Agents