Neurodevelopmental disorders, specifically autism spectrum disorder and early learning disabilities in offspring of pregnant women with folate receptor alpha autoantibodies Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomly assigned in a 1:1 ratio using a computer-generated randomisation list. Allocation concealment will be ensured through the use of sealed, opaque envelopes. Both participan
Sponsors
Altamedica
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women in the first trimester of gestation 2. Singleton pregnancy (no multiple gestation) 3. Age between 18 and 42 years 4. Positive for folate receptor alpha autoantibodies (FRAA) — either blocking or binding type 5. Nulliparous (no previous pregnancies beyond 20 weeks) 6. Willing and able to provide written informed consent 7. Willing to comply with the intervention and follow-up schedule until 24–30 months postpartum
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancy (e.g., twins or more) 2. Presence of genetic or structural fetal abnormalities detected at baseline 3. Maternal epilepsy or current use of antiepileptic drugs 4. Maternal diabetes mellitus (pre-gestational or gestational) 5. Chronic use of antifolate medications (e.g., methotrexate, sulfasalazine) 6. Any serious maternal medical condition that could interfere with participation or outcome assessment 7. Inability or unwillingness to comply with the treatment or follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurodevelopmental benefit is measured as a reduction in the incidence of autism spectrum disorder (ASD), using the M-CHAT-R/F screening tool followed by DSM-5 confirmation, at 24–30 months of age in children of FRAA-positive pregnant women receiving folinic acid versus folic acid | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ASD severity measured using Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) and Autism Diagnostic Interview – Revised (ADI-R) at 24–30 months of age 2. ASD subtype classification measured using ADOS-2 and ADI-R at 24–30 months of age 3. Cognitive development measured using the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) at 24–30 months of age 4. Early learning ability measured using the Mullen Scales of Early Learning at 24–30 months of age 5. Adaptive behavior measured using the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) at 24–30 months of age | — |
Countries
Italy
Contacts
Public ContactAlvaro Mesoraca
Outcome results
None listed