N-CAD levels and resting brain activity in children with autism and typical peers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study recruits children aged 3 to under 5 years with autism and age-matched typically developing (TD) children and collects demographic data, neuropsychological assessments, and peripheral blood samples. Plasma N-CAD concentration will be measured from 3 ml blood samples that are rapidly processed and frozen, while resting-state brain activity will be recorded using functional near-infrared spectroscopy (fNIRS), with simultaneous monitoring during Gesell assessment. The planned sample size is about 49 children per group to provide adequate statistical power for group comparisons. Group differences in plasma N-CAD and fNIRS-derived measures will be tested using standard statistical methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age at enrollment ≥ 3 years and \<5 years;
2. The diagnosis was made by 2 developmental behavioral pediatricians or child psychiatrists with vice senior titles or above, and the history and clinical manifestations were in line with ASD and ICD-11 diagnostic criteria for ASD; .

Exclusion Criteria:

1. Diagnosis or manifestation of genetic diseases or syndromes related to ASD (such as Rett syndrome);
2. Medical or nervous system diseases affecting growth, development or cognition (such as central nervous system infection, epilepsy, congenital heart disease, etc.);
3. Sensory impairment such as vision or hearing loss;
4. Low birth weight (birth weight \<2000 g) or preterm birth (gestational age \<37 weeks);
5. Adopted children;
6. Parents refused to sign the informed consent form;
7. Other researchers consider it inappropriate to participate in the study.

Where it's running

• Growth, Development and Mental health of Children and Adolescence Center
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Li Chen, doctor
• Email: chenli2012@126.com
• Phone: 13677620103

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.