- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01172236
Supplementation With Lactoferrin in Preterm Newborns (lactoprenew)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main source of food for newborns is breast milk or formula. Breast milk contains heme Fe consequently the non-heme Fe, which is bound to milk proteins and other substances with lower molecular weight, is the main source of Fe in the diet of infants. The child is able to regulate the absorption of iron from the gut, in response to supplementation, only near the first year of life,18 so the inability of infants to regulate the intestinal absorption predisposes them to a deficiency when the Fe in the diet is insufficient, or an overload, when levels in the diet are high. It was also suggested that the enrichment of Fe in young children may lead to an increase in its plasma concentration and the formation of nonspecific compounds (nonspecific binding to proteins with low affinity bonds) that give rise to the so-called free Fe (NPBI) which originate from reactive oxygen species. Some authors have demonstrated increased oxidative stress in infants of very low birth weight who were subjected to a large oral iron supplementation, especially if breastfed seno.19-21 Although gestational age and some clinical treatments such as transfusions and ventilation considered because of an increased risk of oxidative damage Fe-indotto.22 Since the status of Fe in breast-fed term infants is usually satisfactory, at least until the sixth month, and an important part of Fe in human milk is bound to lactoferrin, has been previously suggested that the effect protective of human milk is related to the presence of this protein fixing most of the Fe and regulates its absorption. The lactoferrin is an iron-binding protein, naturally found in high concentrations in breast milk and in low concentrations in other fluids esocrini23. For the size and structure of lactoferrin is closely linked to another group of Fe-related protein, the transferrin and is considered by many as a member of this family. Lactoferrin binds iron with high affinity binding and its structure is unusually resistant to proteolytic degradation. Besides regulating the absorption of iron during inflammatory processes and infettivi24 performs several physiological functions including antibacterial, antifungal, antivirale25, antiparassitary26, antitumoral27, immunomodulator28-29. This ability antibacterial and antiviral properties, may explain the low prevalence and shorter duration of infection in breast-fed infants. In human milk lactoferrin plays an antioxidant sequestering free ions of Fe30 and thus preventing lipid peroxidation and subsequent milk oxidation31. Some AA.32 have shown this property in vitro using salts and Fe ions in the presence of a biological agent such as reducing ascorbato33. A recent study has also demonstrated its antioxidant effect in blood34. Again lactoferrin is able to bind free Fe, from binding studies, avoiding be sure to trigger a series of chain reactions that produce free radicals and thus reduces the damage induced by oxidative stress. This explains why breastfed children have significantly higher total antioxidant capacity and significantly lower index of oxidative stress. A recent study on infants supplied with formula supplemented with lactoferrin showed that presence of this protein helps the absorption of Fe in the small gut. The same study suggests that its activity could stimulate the proliferation and differentiation of mucosal cells in the gut35, thus increasing the surface and in turn increase the absorption of nutrients. Studies in pregnancy women 36 suggests that lactoferrin may have an anti-inflammatory effect, while also improving the Fe status of women.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEO-LF100-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Birth Weight
-
Society for Applied StudiesGrand Challenges CanadaCompleted
-
Foundation for Advanced Studies on International...St.Luke's Life Science Institute, Tokyo, JapanCompleted
-
Society for Applied StudiesCentre For International HealthCompleted
-
Nantes University HospitalTerminated
-
OSF Healthcare SystemCompleted
-
The Hospital for Sick ChildrenCompletedInfant, Low Birth WeightCanada, Bangladesh
-
Rajiv BahlEmory University; Hawassa University; Mekelle University; Emory University EthiopiaCompleted
-
Addis Ababa UniversityWorld Health Organization; Harvard School of Public Health (HSPH)CompletedLow Birth-weightEthiopia
-
Meiji Co., Ltd.CompletedLow Birth Weight InfantsThailand
-
Aga Khan UniversityBill and Melinda Gates FoundationUnknownLow-Birth-Weight InfantPakistan
Clinical Trials on Lactoferrin
-
Sunnybrook Health Sciences CentreNational Health and Medical Research Council, Australia; Canadian Institutes...Active, not recruitingMorbidity;Newborn | Preterm Infant | Very Low Birth Weight InfantCanada
-
Inner Mongolia Yili Industrial Group Co., LtdCompletedCommon Cold | Human Influenza | ImmunizationChina
-
Midwest Center for Metabolic and Cardiovascular...HelainaCompletedImmune HealthUnited States
-
Ain Shams UniversityCompletedNeonatal Sepsis
-
Universidad Peruana Cayetano HerediaCompleted
-
Centre Hospitalier de ValenceCompletedMetallic TasteFrance
-
Cairo UniversityUnknown
-
University of VirginiaThe Gerber FoundationUnknownTolerance | Safety Issues | Very Low Birth Weight Infant
-
Ankara UniversityCompletedVery Low Birth Weight Infants | Necrotising Enterocolitis | Late Onset Neonatal SepsisTurkey