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Supplementation With Lactoferrin in Preterm Newborns (lactoprenew)

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ClinicalTrials.gov Identifier: NCT01172236
Recruitment Status : Completed
First Posted : July 29, 2010
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Giuseppe Buonocore, 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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

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
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Responsible Party: Giuseppe Buonocore, Professor, University of Siena
ClinicalTrials.gov Identifier: NCT01172236    
Other Study ID Numbers: NEO-LF100-2010
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: April 2010
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Lactoferrin
Anti-Infective Agents