Identifying biomarkers for neurodevelopmental disorders linked to inflammation during pregnancy
Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL
This study is trying to find signs that could help predict neurodevelopmental disorders in kids whose moms had inflammation during pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Pisa, PI) |
| Trial ID | NCT06852703 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictive biomarkers for neurodevelopmental disorders in children whose mothers experienced inflammation during pregnancy. It will involve 300 pregnant women and their children, with biological samples collected at various stages of pregnancy to assess immune responses. The study will also utilize a controlled mouse model to explore the molecular mechanisms connecting maternal inflammation to altered brain development. The integration of these approaches seeks to provide early indicators and potential intervention strategies for affected children.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 40 with a normal BMI and no significant medical or obstetric history.
Not a fit: Patients with pre-gestational diabetes, multiple pregnancies, or significant obstetric complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and intervention strategies for neurodevelopmental disorders in children.
How similar studies have performed: While the association between maternal inflammation and neurodevelopmental disorders is established, this specific approach to identifying biomarkers is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age between 18 and 40 years. BMI between 18 kg/m2 and 25 kg/m2. Negative remote medical history for chronic conditions (rheumatological, immunological, endocrinological). Negative obstetric history for significant pathologies (pre-eclampsia, gestational diabetes, preterm birth). Reassuring combined test Exclusion Criteria: * Pre-gestational diabetes * Multiple pregnancy * Threatened preterm labor and/or premature rupture of membranes * Pre-eclampsia * Intrauterine growth restriction (IUGR) * Fetal macrosomia (biometrics \>90th percentile) * Chromosomal syndromes, genetic conditions, or multiple fetal malformations or major fetal malformations * Withdrawal of informed consent * Smoking patients are not excluded from the study, nor are patients who develop gestational diabetes during pregnancy.
Where this trial is running
Pisa, PI
- Aoup — Pisa, Pi, Italy (Recruiting)
Study contacts
- Study coordinator: Antonella Pisano, Dr.
- Email: contratti.ricerca@humanitas.it
- Phone: +39 02 82244501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.