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NCT Number: NCT06487286

Levels of Visfatin/NAMPT in Human Milk

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.

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Key information

Conditions

Visfatin Levels in Maternal Milk Samples Behavior Birth Weight Body Weight Breast Feeding Feeding Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale degli Infermi - ASL BI

Ponderano, BI, 13875, Italy

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

observational study

Primary outcomes

  1. Visfatin levels

    Time frame: 48 hours, 7 days and 30 days

    Visfatin levels in maternal milk samples

  2. Visfatin levels

    Time frame: 1-2 days post-partum

    Visfatin levels in maternal plasma/serum

Secondary outcomes

  1. values of Visfatin

    Time frame: 6 months

    correlate the values of Visfatin to different demographic and clinical characteristics of the lactating mothers

  2. values of Visfatin

    Time frame: 6 months

    correlate the values of Visfatin to different biological/clinical features of the newborns; in particular, we will focus attention on the weight loss of the neonate

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Manzoni, Professor

CONTACT

[email protected]

+39 01515156906

Sponsors and collaborators

Lead sponsor

Paolo Manzoni Study Group

Other

Collaborators

  • Università degli Studi del Piemonte Orientale Amedeo Avogadro

Registry information

Official study title

Levels of Visfatin/NAMPT in Human Milk.VISFAMILK

Acronym: VISFAMILK

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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