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Recruiting NCT06487286

Levels of Visfatin/NAMPT in Human Milk

Observational Visfatin Levels in Maternal Milk Samples Birth Weight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational study.
Who it may be relevant to
Registry conditions: Visfatin Levels in Maternal Milk Samples, Birth Weight. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Levels of Visfatin/NAMPT in Human Milk.VISFAMILK

Overview

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.

Interventions

  • Other observational study
    observational study

Primary outcome measures

  • Visfatin levels [Time frame: 48 hours, 7 days and 30 days]
  • Visfatin levels [Time frame: 1-2 days post-partum]
Secondary outcome measures (2)
  • values of Visfatin [Time frame: 6 months]
  • values of Visfatin [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Ospedale degli Infermi - ASL BI — Ponderano

Identifiers

NCT: NCT06487286 · 4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗