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Evaluation of Clinical Performance of INFANTIX in a Maternity Hospital
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Comparando dos revisiones:
6 Septiembre 2022 - 3:25pm
por CNEURO
19 Diciembre 2025 - 10:57pm
por Gladys
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Revisión actual:
Evaluation of Clinical Performance of INFANTIX in a Maternity Hospital
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
ECPMH-INFANTIX
Scientific title:
Evaluation of Clinical Performance in a Maternity Hospital of the NEURONIC/INFANTIX Neonatal Screening System A6.2
Acronym of Scientific Title:
ECPMHNINSS
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Cuban Neurosciences Center
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Cuban Neurosciences Center (CNEURO) and Ministery of Public Health from Cuba (MINSAP).
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Authorization date :
28/07/2022
Reference number:
05.001.22Q
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Alejandro
Last name:
Torres-Fortuny
Medical Specialty :
Second Degree Specialist in Clinical Neurophysiology
Affiliation:
Cuban Neurosciences Center
Postal address:
Calle 190 #19818 E/ Ave. 25 y 27, Rpto. Cubanacan, Playa
City:
Havana
País:
Cuba
Zip Code:
15202
Telephone:
+53-78301372
Email address:
fortuny@cneuro.edu.cu
alejofortuny@gmail.com
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Havana, "Ramon Gonzalez Coro" Gyneco Obstetric hospital, Belinda Ramirez Hernandez, MD. First Degree Specialist in Normal and Pathological Physiology
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
06/09/2022
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Hearing and vision disorders in newborns
Health condition(s) code:
Healthy Volunteers
Intervention(s):
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, and the second can be done at any time within a 24-hour interval after the first test. Each test will be performed only once for each ear, in the event that the result is PASS. In the event that the result of the test is REFER, it will be repeated once more, registering the second result as definitive. Audix 5 (Control group): A BAEP test will be carried out, in a time range of 24 hours, before or after, to the performance of the first test. For Brain Stem Evoked Potentials test (BAEP) Infantix (Experimental group): A test will be performed on both ears. The test will be performed only once for each ear, in the event that the result is PASS. In the event that the result of the test is REFER, it will be repeated once more, registering the second result as definitive. Audix 5 (Control group): A test will be carried out, in a time range of 24 hours, before or after the completion of the first test. For Visual Evoked Potentials test (VEP) Infantix (Experimental Group): Two tests will be performed on both eyes. The test will be performed only once for each eye, in the event that the result is PASS. In the event that the result of the test is REFER, it will be repeated once more, registering the second result as definitive. Neuronica 5 (Control Group): A single test will be performed within an interval of 24 hours after the first test.
Intervention code:
Diagnostic Equipment
Intervention keyword:
INFANTIX NEURONICA 5 AUDIX 5
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
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)
Key secondary outcomes:
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
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
2 days
Maximum age:
14 days
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.
Type of population:
Children
Type of participant:
Healthy volunteers
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Screening
Allocation:
Non-randomized controlled trial
Masking:
Single Blind
Control group:
Active
Study design:
Other
Other design:
There will be three groups, one per test. An individual could be in several groups at the same time.
Phase:
N/A
Target sample size:
300
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Ernesto
Last Name:
Velarde-Reyes
Specialty:
Master in Digital Systems. Telecommunications and Electronics Engineer.
Affiliation:
Cuban Neurosciences Center
Postal Address:
Calle 190 #19818 E/ Ave. 25 y 27, Rpto. Cubanacan, Playa
City:
Havana
País:
Cuba
Zip Code:
15202
Telephone:
+53-72637222
Email :
velarde@cneuro.edu.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Alejandro
Last Name:
Torres-Fortuny
Specialty:
Second Degree Specialist in Clinical Neurophysiology.
Affiliation:
Cuban Neurosciences Center
Postal Address:
Calle 190 #19818 E/ Ave. 25 y 27, Rpto. Cubanacan, Playa
City:
Havana
País:
Cuba
Zip Code:
15202
Telephone:
+53-78301372
Email :
fortuny@cneuro.edu.cu
alejofortuny@gmail.com
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
Yes
Description of Data Sharing Plan:
Patient test records will be shared, as well as data dictionaries and results for each patient (name encrypted). The data will be available within a maximum period of 6 months after the end of the trial. To obtain the data, you must write to the essay monitor, at velarde@cneuro.edu.cu.
Additional information to share:
The protocol and data collection notebooks will be shared (After the end of the trial).
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
“Ramon Gonzalez Coro” Gyneco Obstetric hospital
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
02/03/2022
Postal address of Ethic Committee :
Calle 21 #854 E/ 4 y 6, Vedado, Plaza de la Revolucion. La Habana, ZC:10400, Cuba
Telephone:
+53-78382611
Correo electrónico:
hgcoro@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Study completion date:
04/08/2022
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000405
Date of Registration in Primary Registry:
27/04/2022
Record Verification Date:
2025/12/19
Next update date:
2026/12/19
Link to the spanish version:
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