Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults

Condition(s) studied

Investigational drug(s) / intervention(s)

Infection during pregnancy: any bacterial or viral infection acquired during pregnancy

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

Eligibility

Primary outcome measure(s)

• Biomarkers analysis on blood samples collected from healthy and infected mothers — 32 month
  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.
• Sonographic examination at fetal level — Once during the second and the third trimester of pregnancy
  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
• Sonographic examination at fetal level — Once during the second and the third trimester of pregnancy
  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)
• Sonographic examination at fetal level — Once during the second and the third trimester of pregnancy
  Brain ultra-sound study involves axial, coronal and sagittal planes to obtain quantitative anatomic parameters (in angle) related to Sylvian fissure (coronal plan)
• Sonographic examination at fetal level — Once during the second and the third trimester of pregnancy
  Quantitative and qualitative evaluation of fetal movements including, Flexion and extension of fetal of arms or legs, Sucking movements, Swallowing movements, Situation changes (longitudinal or trasversal) or presentation changes (cephalic, breech), Breathing movements
• Newborns: assessment of spontaneous movements — 3 times between birth and 20 weeks post-term
  Assessment of spontaneous movements based on Prechtl method of general movements assessment. From longitudinal videorecordings performed by the parents in a structured home setting, we will assess the GM optimality score. The scale between 0 and 38 points from 0-9 weeks post-term; and 5-28 points from 10-20 weeks post-term. A lower score means poorer predicted motor outcome
• Infant behavioral and motor assessment — 12 months infant age
  Infant behavioral and motor assessment according to Alberta Infant Motor Scale. The scale is between 0 and 58 points. A lower score on the Alberta Infant Motor Scale (AIMS) indicates delayed or less advanced motor development

Trial sites (1)

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