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Supplementation With Lactoferrin in Preterm Newborns (lactoprenew)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Siena.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Siena
ClinicalTrials.gov Identifier:
NCT01172236
First received: July 28, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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 Intervention Phase
Prematurity
Low Birth Weight
 Drug: Lactoferrin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Supplementation With Lactoferrin in Preterm Newborns

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Siena:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1300
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   23 Weeks to 32 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Giuseppe Buonocore, University of Siena Italy
ClinicalTrials.gov Identifier: NCT01172236     History of Changes
Other Study ID Numbers: NEO-LF100-2010
Study First Received: July 28, 2010
Last Updated: July 28, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013