Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorIstituto Clinico Humanitas

About this trial

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

Eligibility criteria

Qualifiers

None

Disqualifiers

Pre-gestational diabetes

Multiple pregnancy

Threatened preterm labor and/or premature rupture of membranes

Pre-eclampsia

Trial design

Treatments tested in this trial

  • Infection during pregnancy

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Istituto Clinico Humanitas

Lead sponsor

IRCCS Fondazione Stella Maris

Collaborator

Azienda Ospedaliero, Universitaria Pisana

Collaborator