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Identification of neonatal hearing impairment: experimental protocol and database management
W A Harrison1, J J Dunnell, K Mascher
1Multicenter Consortium on Identification of Neonatal Hearing Impairment, Seattle, Washington, USA.
Ear and Hearing
|November 4, 2000
Summary
This study details the protocol and data management for the Identification of Neonatal Hearing Impairment (INHI) project. Robust data collection and management ensured accurate hearing screening results for infants.
Area of Science:
- Audiology and Hearing Science
- Biomedical Data Management
- Pediatric Health Research
Background:
- Neonatal hearing impairment affects 1-3 per 1000 live births, necessitating effective screening protocols.
- Standardized data collection and management are crucial for multi-center research projects like the Identification of Neonatal Hearing Impairment (INHI) project.
- Accurate data ensures reliable feedback, protocol adherence, and facilitates answering critical research questions.
Purpose of the Study:
- To outline the comprehensive protocol for the Identification of Neonatal Hearing Impairment (INHI) project.
- To describe the data management techniques employed to ensure data accuracy, consistency, and accessibility.
- To establish a framework for effective multi-center research in neonatal hearing screening.
Main Methods:
- Prospective, randomized study evaluating auditory brain stem responses, transient evoked otoacoustic emissions, and distortion product otoacoustic emissions.
- Inclusion of three infant groups: neonatal intensive care unit (NICU) infants, well babies with risk factors, and well babies without risk factors.
- Standardized computerized testing across six centers, with data electronically transmitted and merged into a central database for analysis and feedback.
Main Results:
- The protocol involved a regimented application of three screening measures and detailed collection of clinical/demographic data.
- Monthly reports monitored enrollment, data completeness, and integrity, supplemented by data audits.
- Data management techniques successfully ensured data quality, enabling detailed analysis of screening tool performance and influencing factors.
Conclusions:
- The INHI project's protocol represented a significant advancement in neonatal hearing screening procedures.
- Effective data management was instrumental in maintaining data quality and facilitating comprehensive analyses.
- The study demonstrated the importance of rigorous protocols and data management for reliable research outcomes in neonatal hearing impairment.
