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
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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 |

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 |

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. |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 23 Weeks to 32 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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: | 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 |
Birth Weight Body Weight Lactoferrin Anti-Infective Agents |