NCT06487286

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2025

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

June 27, 2024

Last Update Submit

November 12, 2024

Conditions

Visfatin Levels in Maternal Milk SamplesBirth Weight

Keywords

NewbornsVisfatinBreastfeeding

Outcome Measures

Primary Outcomes (2)

  • Visfatin levels

    Visfatin levels in maternal milk samples

    48 hours, 7 days and 30 days

  • Visfatin levels

    Visfatin levels in maternal plasma/serum

    1-2 days post-partum

Secondary Outcomes (2)

  • values of Visfatin

    6 months

  • values of Visfatin

    6 months

Interventions

observational studyOTHER

observational study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 women, hospitalized after childbirth, with respective healthy, breastfed infants

You may qualify if:

  • 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

You may not qualify if:

  • Refusal of the patient to participate in the study
  • Presence of hypogalactia or agalactia in the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale degli Infermi - ASL BI

Ponderano, BI, 13875, Italy

RECRUITING

MeSH Terms

Conditions

Birth WeightBreast Feeding

Interventions

Observation

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Paolo Manzoni, Professor

CONTACT

+39 01515156906paolo.manzoni@aslbi.piemonte.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Head of Department of Maternal, Neonatal and Infant Medicine, Associate Professor

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

October 24, 2024

Primary Completion

April 23, 2025

Study Completion

April 23, 2025

Last Updated

November 14, 2024

Record last verified: 2024-11

Locations

IT(1)