Evaluation of Clinical Performance of INFANTIX in a Maternity Hospital
Not Applicable
Recruiting
- Conditions
- Hearing and vision disorders in newbornsHealthy Volunteers
- Registration Number
- RPCEC00000405
- Lead Sponsor
- Cuban Neurosciences Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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
1- Those newborns with some serious pathology that prevents their manipulation in that period are excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1- Result of the screening tests with OAE (Pass or Refer). Measurement time: At the end of the test. <br>2- Results of the screening tests with BAEP (Pass or Refer). Measurement time: At the end of the test. <br>3- Result of screening tests with VEP using goggle (Pass or Refer). Measurement time: At the end of the test<br><br>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 Outcome Measures
Name Time Method 1- Duration time of the OAE screening tests (time in seconds that each test takes). Measurement time: At the end of the test<br>2- Duration time of the screening tests with BAEP (time in seconds that each test takes). Measurement time: At the end of the test<br>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