Actively Recruiting
Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults
Led by Istituto Clinico Humanitas · Updated on 2025-02-28
300
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
I
Istituto Clinico Humanitas
Lead Sponsor
I
IRCCS Fondazione Stella Maris
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 40 years
- Body mass index (BMI) between 18 kg/m2 and 25 kg/m2
- No chronic rheumatological, immunological, or endocrinological conditions in medical history
- No significant pregnancy complications such as pre-eclampsia, gestational diabetes, or preterm birth
- Reassuring combined test results
You will not qualify if you...
- Pre-gestational diabetes
- Multiple pregnancy
- Threatened preterm labor or premature rupture of membranes
- Pre-eclampsia
- Intrauterine growth restriction (IUGR)
- Fetal macrosomia (biometrics >90th percentile)
- Chromosomal syndromes, genetic conditions, or multiple or major fetal malformations
- Withdrawal of informed consent
- Smoking or development of gestational diabetes during pregnancy does not exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AOUP
Pisa, PI, Italy, 56126
Actively Recruiting
Research Team
A
Antonella Pisano, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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