N/A
N=81
Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03971578 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: ABR Peak V Latency — 6; 5.8; 6.29; 5.99 ms
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention Provided (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Intelligent Hearing Systems
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ABR Peak V Latency |
6; 5.8; 6.29; 5.99; 6.48; 6.26 | — |
Summary
The purpose of this study is to develop an Auditory Brainstem Response (ABR) based neurological screening method to detect increased risk for Autism Spectrum Disorders (ASD) and other neurological conditions in newborns.
Eligibility Criteria
Inclusion Criteria
- Children with autism spectrum disorder diagnosis
- Normally developing age- and gender-matched controls
Exclusion Criteria
- Permanent or temporary hearing loss at the time of testing.
- Craniofacial abnormalities
Data sourced from ClinicalTrials.gov (NCT03971578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.