Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to Diagnose Autism Spectrum Disorder in Early Childhood.
Who can participate
Age range18 Months – 48 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age of greater or equal to 18 months and less than or equal to 48 months
* Fulfills the definition of an autism spectrum disorder, developmentally delayed, or typically developing child in the age range 18-48 months, as determined by a clinician or certified practitioner of the appropriate tests and who is knowledgeable in the field; and
* Has parental (or other legal guardian ) informed consent to participate.
Exclusion Criteria:
* Diagnosis with a chronic condition that could interfere with a diagnosis of ASD or DD, (e.g.: a known history of Fragile X, Rett syndrome, Down syndrome, tuberous sclerosis, trisomy 21, inborn errors of metabolism or other genetic disorder that includes some symptoms of autism)
* Fetal alcohol syndrome, or other serious neurological disorder
* Other serious metabolic disorder, psychiatric disorder, or medical condition involving the liver, kidney, pulmonary, cardiovascular or endocrine systems
* A second child within a family in which a sibling has already been enrolled.
* A child who has previously participated in the CAMP-01 study
What they're measuring
1
Metabolites in plasma indicative of autism spectrum disorder.