Status:
UNKNOWN
MAP Autism Prediction Study
Lead Sponsor:
BioROSA Technologies Inc
Collaborating Sponsors:
Melmed Center
Vanderbilt University
Conditions:
Autism Spectrum Disorder
Developmental Delay
Eligibility:
All Genders
18-60 years
Brief Summary
This pilot clinical trial tests the hypothesis that certain blood metabolite levels can be used to predict Autism Spectrum Disorder (ASD). The study cohort will consist of 200 participants between the...
Detailed Description
The primary objective is to conduct a double-blind, proof-of-concept, two-site, prospective study of 200 children aged 18-60 months that have been referred for an ASD evaluation by a physician to asse...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 18-60 months of age
- Primary language is English (this is due to the evaluation instruments being used, which are in the English language).
- Suspected developmental concern and referral to the developmental center by child's physician
- Parental informed consent to participate in the study (based on the age range of the children in this study, assent is being waived)
- Willingness to comply with all study procedures
- Not currently enrolled in another clinical trial
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Previous diagnosis of ASD or DD
- Prematurity \< 34 weeks' gestation
- Has a sibling already enrolled in the trial
- Profound sensory deficits (e.g., hearing and vision deficits) that could interfere with the interpretation of study results
- Documented current or active seizures, as defined by a clinical seizure or abnormal EEG within the past six months
- Major genetic defect as determined by chromosomal microarray or other method of genetic detection
- Currently taking any high dose (greater than recommended daily allowance) dietary supplements
- Diagnosis or suspicion of recent viral/bacterial infection within 2 weeks of enrollment
- Diagnosis with congenital brain malformations, moderate to severe traumatic brain injury, congenital or acquired microcephaly, or infection of the central nervous system (e.g., meningitis, viral encephalitis)
- Fetal alcohol syndrome, Down syndrome, or another recognized syndrome
- Usage of acetaminophen (e.g., Tylenol) within the past 72 hours
- Fever (temperature \> 100 degrees Fahrenheit) within the past 72 hours
- Any other reason that the clinical investigator feels may place the participant at an unnecessary risk to participate
Key Trial Info
Start Date :
November 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04672967
Start Date
November 3 2021
End Date
October 1 2022
Last Update
November 10 2021
Active Locations (1)
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1
VUMC
Nashville, Tennessee, United States, 37212