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Evaluation of new OAE- and ASSR-measurement methods for newborn hearing screening

Evaluation of new OAE- and ASSR-measurement methods for newborn hearing screening - NewScreen

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038104
Enrollment
81
Registered
2025-10-13
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing loss due to conductive or sensorineural hearing impairment, other hearing loss, congenital or early childhood hearing loss

Interventions

Group 1: The study population consists of infants aged 0 to 6 months who are presented at the clinic for newborn hearing screening, follow-up examination of an abnormal newborn hearing screening resul

Sponsors

Klinik für Phoniatrie und Pädaudiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Months

Inclusion criteria

Inclusion criteria: Infants who are presented to the clinic for newborn hearing screening, follow-up testing of an abnormal newborn hearing screening result, or follow-up testing of an abnormal (external) follow-up examination after a previously abnormal newborn hearing screening result. Parental consent: Parents must give their informed consent before the study can begin.

Exclusion criteria

Exclusion criteria: • Children with serious health problems that would not allow for an extension of the examination, e.g., severe heart defects, severe neurological diseases • Routine diagnostics that cannot be performed in full • Children whose parents/medical representatives do not give informed consent

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity for ASSR vs. AABR

Secondary

MeasureTime frame
• Number of frequency bands required from three measured bands needed for a valid result in AASSR • Measurement duration of AASSR vs. AABR • Sensitivity and specificity as well as positive and negative predictive value for ATEOAE with vs. without noise canceling (NC)

Countries

Germany

Contacts

Public ContactKatrin Johanna Neumann

Klinik für Phoniatrie und Pädaudiologie

katrin.neumann@uni-muenster.de004925156871

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026