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

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

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

Date of available results:

06/01/2023

Date of first publication:

06/01/2023

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:

2022/09/06

Next update date:

2023/09/06

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Evaluation of Clinical Performance of INFANTIX in a Maternity Hospital

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