2010 RTOI: Assessing New Technology and Averaging Algorithm for Obtaining Non-Sedated Frequency Specific Auditory Brainstem Evoked Response Thresholds in Neonates

August 17, 2010

Duration:
Two Years

Level of Funding:
$100,000 per year

Project Description:
With 50 states and 7 territories conducting universal newborn screening, the need for an efficient method of hearing assessment must follow a failed screen. Some diagnostic facilities are currently using sedation to facilitate hearing assessment. The purpose of this grant is to explore any technique or technology (existing or new) that can be incorporated in electrophysiological testing that will facilitate hearing loss diagnosis in newborns without the use of sedation.

Study Focus:

1. Identify any existing technique or technology that can be incorporated in electrophysiological testing that will facilitate hearing threshold estimation in infants without the use of sedation
2. Evaluate the feasibility of incorporating the technique and or technology in electrophysiological tests for successful threshold estimation
3. Evaluate the reliability of the technique and or technology in successful threshold estimation for non-sedated infants in electromagnetically noisy environment and a non-shielded quiet room in an outpatient clinic setting
4. Compare new technologies and averaging algorithms for obtaining non-sedated frequency specific ABR to currently used technologies and signal averaging algorithms in order to estimate auditory thresholds in infants and young children.
5. Compare the time required to complete an electrophysiological diagnostic test with and without the incorporated technique or technology in non-sedated infants

Evaluation Criteria:

Although a wide range of proposals may be considered, it is important that the applicant clearly outline the objectives and design of the study as well as the statistical analyses that will be used. Key questions the researcher will address must be clearly outlined and a justification for the particular design of the study should be provided.

 

Successful applications must include the following:

1. Plans to establish collaborative relationships with involved stakeholders such as staff from state health departments, universities, or private organizations
2. Description of the research and analytic plan, including timeline of activities
3. Methods to be used to define and identify the study population and expected sample size
4. Description of benefits and barriers of data collection
5. Description of the technique and or technology that will be incorporated in the electrophysiological diagnostic test battery
6. Description of how the technique and or technology may help in diagnosing hearing loss in non-sedated infants in sub-optimal clinic setting
7. Description of the test environment where the study will be conducted
8. Plans for submission of progress and final reports, and dissemination of findings
9. Detailed budget, including identification of sub-contractor
10. Protection of human subjects

 

Preferences will be given to applicants who:

1. Demonstrate knowledge of and experience with the proposed research methodology
2. Have prior experience in electrophysiological testing with neonates in various clinical settings
3. Have prior experience in conducting the specific research methodology proposed
4. Demonstrated history of their dissemination of research findings
5. Demonstrate knowledge of and experience with various research methodologies
6. Demonstrate knowledge and experience with electrophysiological testing in infants in sub-optimal testing environments
7. Demonstrate knowledge with the latest electrophysiological test methods and innovation

 

The applicant should clearly describe all aspects of the proposed study, including (but not limited to) the justification for choosing the specific study topic, the precise methodology chosen with justification for using the methodology, and the analytic framework and statistical analyses that will be used. If the researcher plans to collaborate with other partners, such as state agencies, universities, or private organizations, the letter should indicate that these partners have been contacted and are willing to participate.

 

A Letter of Intent (LOI) should demonstrate the researcher has an understanding of the issues surrounding hearing loss diagnosis in pediatric population, the specific type of research methodology, conventional or new technique or technology that can be used in electrophysiology measurement of hearing.

 

The LOI should:

• Provide clear evidence of a working knowledge and experience in electrophysiological testing of neonates in various clinical settings.
• Provide an overview of the proposed research design and analytic plan, including planned statistical analyses.
• Clearly indicate experience with the proposed research methodology and statistical analyses.
• If needed provide clear evidence of prior success collaborating with state EHDI programs and other public health staff.