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
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Pre-gestational diabetes
Multiple pregnancy
Threatened preterm labor and/or premature rupture of membranes
Pre-eclampsia
Trial population
Not applied
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Infection during pregnancy
Other interventionany bacterial or viral infection acquired during pregnancy
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Control0 interventions
Group B: diseased1 intervention
Trial outcomes
Primary outcomes
1
Biomarkers analysis on blood samples collected from healthy and infected mothers
Assesment of the immune profile in both cohorts recruited. In particular, we will measure the circulating levels of IL-6, CRP, PCT, TSH and Vitamine D at 20 and 30 weeks gestation to obtain a longitudinal immune profile across gestation. The analysis will be carried out using ELISA kit in the serum collected from both cohorts.
Time frame
32 month2
Sonographic examination at fetal level
Brain ultra-sound study involves axial, coronal and sagittal planes to obtain qualitative anatomic parameters related to Head shape, Integrity of falx cerebri,, Cavum septum pellucidum, Thalami, Insulae lobes, Cerebral hemispheres, Third and fourth ventricles, Parieto-occipital fissure
Time frame
Once during the second and the third trimester of pregnancy3
Sonographic examination at fetal level
Brain ultra-sound study involves axial, coronal and sagittal planes to obtain quantitative anatomic parameters related to (in mm) Head circumference and biparietal diameter (axial plan), Antero-posterior diameter of corpus callosum (sagittal plan), Cerebellum (axial plan), Cerebellar vermis, cranio-caudal diameter (sagittal plan), Lateral ventricles, latero-lateral diameter (axial plan), Cisterna magna, antero-posterior diameter (axial plan)
Time frame
Once during the second and the third trimester of pregnancy4
Sonographic examination at fetal level
Brain ultra-sound study involves axial, coronal and sagittal planes to obtain quantitative anatomic parameters (in angle) related to Sylvian fissure (coronal plan)
Time frame
Once during the second and the third trimester of pregnancySecondary outcomes
1
Newborns: Magnetic resonance imaging (MRI)
Magnetic resonance imaging (MRI) will be performed while the participant is in natural sleep to assess brain structure and function. The following parameters will be measured: Cortical Thickness: Measured in millimeters (mm); higher values indicate thicker cortex.
Time frame
Once between birth and 8 weeks infant age2
Newborns: Magnetic resonance imaging (MRI)
Magnetic resonance imaging (MRI) will be performed while the participant is in natural sleep to assess brain structure and function. The following parameters will be measured: Volumes: Measured in cubic millimeters (mm³) for brain regions; larger volumes may indicate more developed structures
Time frame
Once between birth and 8 weeks infant age3
Newborns: Magnetic resonance imaging (MRI)
Magnetic resonance imaging (MRI) will be performed while the participant is in natural sleep to assess brain structure and function. The following parameters will be measured: Gyrification: Quantified as a gyrification index (dimensionless ratio); higher values reflect more cortical folding.
Time frame
Once between birth and 8 weeks infant age4
Newborns: Magnetic resonance imaging (MRI)
Magnetic resonance imaging (MRI) will be performed while the participant is in natural sleep to assess brain structure and function. The following parameters will be measured: Connectivity: Measured using structural metrics: fractional anisotropy and mean diffusivity.
Time frame
Once between birth and 8 weeks infant ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto Clinico Humanitas
Lead sponsor
IRCCS Fondazione Stella Maris
Collaborator
Azienda Ospedaliero, Universitaria Pisana
Collaborator
Source ClinicalTrials.gov