Visfatin Levels in Maternal Milk SamplesVISFAMILKNCT06487286
Levels of Visfatin/NAMPT in Human Milk
An observational study of Visfatin Levels in Maternal Milk Samples and Birth Weight, run by Paolo Manzoni Study Group at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Visfatin Levels in Maternal Milk Samples, Birth Weight
- What is being tested?
- observational study
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 24 Oct 2024to 23 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 30 women, hospitalized after childbirth, with respective healthy, breastfed infants
Who may be able to join
- 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
Who cannot join
- Refusal of the patient to participate in the study
- Presence of hypogalactia or agalactia in the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale degli Infermi - ASL BI
Ponderano, BI, 13875
About this study
Official title: Levels of Visfatin/NAMPT in Human Milk.VISFAMILK
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.
Read the 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.
- Being tested
- observational study
- Keywords
- Newborns, Visfatin, Breastfeeding
- Medical subject headings
- Birth Weight, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Visfatin levels
Visfatin levels in maternal milk samples
Measured: 48 hours, 7 days and 30 days
Visfatin levels
Visfatin levels in maternal plasma/serum
Measured: 1-2 days post-partum
Secondary outcomes (2)
values of Visfatin
correlate the values of Visfatin to different demographic and clinical characteristics of the lactating mothers
Measured: 6 months
values of Visfatin
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start24 Oct 2024
- Primary completion23 Apr 2025 (estimated)
- Study completion23 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visfatin Levels in Maternal Milk SamplesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paolo Manzoni Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Responsible party
- Sponsor-investigator, Paolo Manzoni Study Group, Paolo Manzoni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487286
- Sponsor's protocol ID
- 4
- Acronym
- VISFAMILK
- Status last verified
- Nov 2024
- First submitted
- 27 Jun 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of Visfatin/NAMPT in Human Milk.VISFAMILK
- ClinicalTrials.gov ID
- NCT06487286
- Acronym / sponsor ID
- VISFAMILK / 4
- Keywords
- Newborns, Visfatin, Breastfeeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Paolo Manzoni Study GroupUniversity, hospital or other
- Collaborators
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 23 Apr 2025 (estimated)
- Study completion
- 23 Apr 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 30 women, hospitalized after childbirth, with respective healthy, breastfed infants
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal of the patient to participate in the study
- Presence of hypogalactia or agalactia in the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobservational study | Other | – |
Primary outcome
Visfatin levels
Time frame: 48 hours, 7 days and 30 days
Visfatin levels in maternal milk samples
Visfatin levels
Time frame: 1-2 days post-partum
Visfatin levels in maternal plasma/serum
2 secondary outcomes
values of Visfatin
Time frame: 6 months
values of Visfatin
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visfatin Levels in Maternal Milk Samples and Birth Weight, run by Paolo Manzoni Study Group at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Manzoni, Professor (+39 01515156906, paolo.manzoni@aslbi.piemonte.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visfatin levels (time frame: 48 hours, 7 days and 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.