Study on one-step AABR screening in newborn hearing screening

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900026353

Enrollment

Unknown

Registered

2019-10-01

Start date

2019-10-01

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Hearing Loss

Interventions

Gold Standard:Diagnostic hearing test: combination of acoustic immittance, DPOAE, click ABR, Tone Burst ABR and cochlear microphonic potential(CM).

Index test:two-step&#32

DPOAE&#32

screening&#32

and&#32

one-step&#32

AABR&#32

screening

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Newborn babies which should accept hearing screening; 2. Signed informed consent.

Exclusion criteria

Exclusion criteria: Ankylotia.

Design outcomes

Primary

Measure	Time frame
screening efficiency;SEN, SPE, +PV, -PV, ACC, AUC of ROC;	—

Countries

China

Contacts

Public ContactYun Li

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

doctor@sh9hospital-ent.com+86 18019790013

Outcome results

None listed

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