Clinical Trial

Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults

Study acronym: MATERNALLY
Recruiting
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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
Trial Details
NCT Number NCT06852703
Lead Sponsor Istituto Clinico Humanitas
Collaborators: IRCCS Fondazione Stella Maris, Azienda Ospedaliero, Universitaria Pisana
Conditions Biomarkers, Neurodevelopmental Disorders, Inflammation, Brain
Enrollment 300 participants
Start Date 2021-09-01
Primary Completion 2024-04-30 (estimated)
Study Completion 2025-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-28