About this trial
The objective of the Pediatric Epidemiological Data and Incidence (PEDI) PANDAS study is to demonstrate the feasibility of enrollment and retention of subjects in a study to determine the incidence and natural history of children with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) with regard to spectrum, course and outcome. The investigators aim to demonstrate they can recruit and retain 85% of children who are eligible for this study. Eligible children are those who fit criteria for PANS and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS). Each child will be followed for one year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Child age 3-17 years old
Child and their parent/guardian are able to complete all study activities in English
Potential participant's family plans to be followed within UW Health or Dartmouth Health for at least one year
Pediatric patient who is a current member of the primary care population at either UW Health or Dartmouth Health
Disqualifiers
History of tics, OCD or food restriction/avoidance that contradicts a history of sudden onset or was present before the onset of this investigation
Current symptom(s) of Pica
Previous participation in the study
Not suitable for study participation at the discretion of the site investigator (e.g., the child does not have verbal or cognitive ability adequate for self-report assessment)
Trial population
Children between the ages of 3 and 17 years with PANS or PANDAS.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Percentage of Eligible Participants Enrolled
To demonstrate that the methods of recruitment are effective, the aim is to enroll 85 percent of children with PANS/PANDAS who meet preliminary eligibility criteria for the study.
Secondary outcomes
Percentage of Participants Retained at 12 months
The secondary endpoint is retention in the study. The investigators hypothesize that at the 12-month visit, 85 percent of the children who are enrolled will still be on study.
Sponsors and contacts
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University of Wisconsin, Madison
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator