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Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults

NCT06852703 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-02-28

No results posted yet for this study

Summary

Inflammation during pregnancy represents an important risk factor for the development of neuropsychiatric disorders in the offspring. Despite clear epidemiological data supporting this association, translational studies aimed at identifying early predictive biomarkers and possible interventional strategies for this pathological condition are still missing. The MATERNALLY proposal aims to assess in a large patient cohort a novel multiparametric approach for the identification of predictive postnatal behavioral and circulating biomarkers. In parallel, a controlled mouse model for maternal immune activation will be exploited to understand the basic molecular mechanism that links inflammation with aberrant neural circuit formation and to unveil possible therapeutic targets. The integration of the two approaches will allow identifying early predictive biomarkers and proof of principle interventional strategies for this condition of high practical relevance to the neonatologist community

Conditions

  • Biomarkers
  • Neurodevelopmental Disorders
  • Inflammation, Brain

Interventions

OTHER

Infection during pregnancy

any bacterial or viral infection acquired during pregnancy

Sponsors & Collaborators

  • IRCCS Fondazione Stella Maris

    collaborator OTHER

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • Istituto Clinico Humanitas

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-04-30
Completion
2025-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06852703 on ClinicalTrials.gov