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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
In the proposed study, a screening method for neurological deficits, with an emphasis on its application to ASD, will be developed and its feasibility demonstrated. The proposed method will utilize high rate stimulation to acquire Auditory Brainstem Responses in order to determine peak latency and amplitude differences in children with ASD compared to non-ASD. Similarly to newborn hearing screening, the output of the screening method will provide an automated pass or refer outcome that can be used by a physician to determine if the child needs further evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism Spectrum Disorders Group | Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old |
| |
| Normal Control Group | Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 3.5 to 4.5 years old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention Provided | Other | No Intervention Provided |
|
| Measure | Description | Time Frame |
|---|---|---|
| ABR Peak V Latency | Auditory Brainstem Response (ABR) peak V latency measurement for the five stimulation rates used in the study. The latency is the time, measured in ms, from the onset of the stimulus to the generation of the response peak component. ABR peak V is the most prominent response peak component in humans. | One Week |
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Inclusion Criteria:
Exclusion Criteria:
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Children with autism spectrum disorders and normally developing age- and gender-matched controls
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Department of Psychology | Coral Gables | Florida | 33124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29087045 | Background | Miron O, Beam AL, Kohane IS. Auditory brainstem response in infants and children with autism spectrum disorder: A meta-analysis of wave V. Autism Res. 2018 Feb;11(2):355-363. doi: 10.1002/aur.1886. Epub 2017 Oct 31. |
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Summary data will be disseminated
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| ID | Title | Description |
|---|---|---|
| FG000 | Autism Spectrum Disorders Group | Children identified as having Autism Spectrum Disorder Age: 2.5 to 7 years old No Intervention Provided: No Intervention Provided |
| FG001 | Normal Control Group | Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 2.5 to 7 years old No Intervention Provided: No Intervention Provided |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Autism Spectrum Disorders Group | Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old No Intervention Provided: No Intervention Provided |
| BG001 | Normal Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ABR Peak V Latency | Auditory Brainstem Response (ABR) peak V latency measurement for the five stimulation rates used in the study. The latency is the time, measured in ms, from the onset of the stimulus to the generation of the response peak component. ABR peak V is the most prominent response peak component in humans. | Posted | Mean | Standard Deviation | ms | One Week |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autism Spectrum Disorders Group | Children identified as having Autism Spectrum Disorder Age: 2.5 to 7 years old No Intervention Provided: No Intervention Provided |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rafael E. Delgado, Director of Research & Development | Intelligent Hearing Systems | 305-668-6102 | redelgado@ihsys.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2019 | Aug 8, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2019 | Aug 8, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2019 | Aug 8, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 3.5 to 4.5 years old
No Intervention Provided: No Intervention Provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Normal Control Group | Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 2.5 to 7 years old No Intervention Provided: No Intervention Provided | 0 | 37 | 0 | 37 | 0 | 37 |
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