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Evaluation of Clinical Performance of INFANTIX in a Maternity Hospital

Evaluation of Clinical Performance in a Maternity Hospital of the NEURONIC/INFANTIX Neonatal Screening System A6.2 - ECPMHNINSS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000405
Enrollment
300
Registered
2022-04-27
Start date
2022-09-06
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Hearing and vision disorders in newborns

Interventions

For Otoacoustic Emissions test (OAE) Infantix (Experimental group): Two tests will be performed on both ears. The first test will be done right after the consent is signed by the parents or guardians,
Diagnostic Equipment
INFANTIX NEURONICA 5 AUDIX 5

Sponsors

Cuban Neurosciences Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 14 Days

Inclusion criteria

Inclusion criteria: 1- All newborns with corrected age from 0 to 2 weeks and with more than 48 hours of birth will be included in the study. 2- The newborns included in the study must have the express voluntary acceptance (informed consent) of the parents or guardians.

Exclusion criteria

Exclusion criteria: 1- Those newborns with some serious pathology that prevents their manipulation in that period are excluded from the study.

Design outcomes

Primary

MeasureTime frame
1- Result of the screening tests with OAE (Pass or Refer). Measurement time: At the end of the test. 2- Results of the screening tests with BAEP (Pass or Refer). Measurement time: At the end of the test. 3- Result of screening tests with VEP using goggle (Pass or Refer). Measurement time: At the end of the test The values of Specificity, Sensitivity, Positive Predictive Value and Negative Predictive Value will also be reported, taking as reference test or gold standard (Control group in Interventions field)

Secondary

MeasureTime frame
1- Duration time of the OAE screening tests (time in seconds that each test takes). Measurement time: At the end of the test 2- Duration time of the screening tests with BAEP (time in seconds that each test takes). Measurement time: At the end of the test 3- Duration time of the VEP screening tests using the goggle (time in seconds that each test takes). Measurement time: At the end of the test

Countries

Cuba

Contacts

Public ContactErnesto Velarde-Reyes

Cuban Neurosciences Center

velarde@cneuro.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026