Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT04672967
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. 18-60 months of age
2. Primary language is English (this is due to the evaluation instruments being used, which are in the English language).
3. Suspected developmental concern and referral to the developmental center by child's physician
4. Parental informed consent to participate in the study (based on the age range of the children in this study, assent is being waived)
5. Willingness to comply with all study procedures
6. Not currently enrolled in another clinical trial
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Previous diagnosis of ASD or DD
2. Prematurity \< 34 weeks' gestation
3. Has a sibling already enrolled in the trial
4. Profound sensory deficits (e.g., hearing and vision deficits) that could interfere with the interpretation of study results
5. Documented current or active seizures, as defined by a clinical seizure or abnormal EEG within the past six months
6. Major genetic defect as determined by chromosomal microarray or other method of genetic detection
7. Currently taking any high dose (greater than recommended daily allowance) dietary supplements
8. Diagnosis or suspicion of recent viral/bacterial infection within 2 weeks of enrollment
9. 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)
10. Fetal alcohol syndrome, Down syndrome, or another recognized syndrome
11. Usage of acetaminophen (e.g., Tylenol) within the past 72 hours
12. Fever (temperature \> 100 degrees Fahrenheit) within the past 72 hours
13. Any other reason that the clinical investigator feels may place the participant at an unnecessary risk to participate
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
60 Months
Study:
NCT04672967
Study Brief:
Protocol Section:
NCT04672967