Levels of Visfatin/NAMPT in Human Milk.VISFAMILK
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Visfatin levels
Study Overview
Brief Summary
Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the weight loss of the neonate.
Detailed Description
The aim of the study is to analyse a retrospective cohort of well characterized mothers in their post-partum period, and to measure Visfatin levels through collection of maternal milk samples. They will be collected in three different moments after the birth (48 hours, 7 days and 30 days) and Visfatin levels will be analysed through an ELISA kit Adipogen. In parallel, the levels of Visfatin will be evaluated in the maternal plasma/serum collected after 1-2 days postpartum.
Lastly, correlations between Visfatin levels and biological/clinical features of mothers and newborns will be explored.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy male and female infants born after 37 weeks' gestation who do not have conditions related to congenital abnormalities
- •Maternal hospitalization
- •Acquisition of the informed consent form signed by the patient
Exclusion Criteria
- •Refusal of the patient to participate in the study
- •Presence of hypogalactia or agalactia in the patient
Outcomes
Primary Outcomes
Visfatin levels
Time Frame: 1-2 days post-partum
Visfatin levels in maternal plasma/serum
Secondary Outcomes
- values of Visfatin(6 months)
Investigators
Paolo Manzoni Study Group
Principal Investigator, Head of Department of Maternal, Neonatal and Infant Medicine, Associate Professor
Paolo Manzoni