Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT00436358
Eligibility Criteria:
Inclusion Criteria:
An IS case deemed eligible for the study must meet the following criteria:
* Subject is an IMSS affiliate
* Subject is being treated/has been treated at one of the IMSS hospitals/medical facilities with IS during the study period.
* Male or female child is \<1 year of age at the time of diagnosis of the IS
* Subject is diagnosed with definite IS
* Written informed consent for definite IS cases is obtained from the parent/guardian/legal representative of the subject.
* Only subjects who the investigator believes will meet the requirements of the protocol should be enrolled in the study.
A death deemed eligible for the study must meet the following criteria:
* Subject is an IMSS affiliate
* Death certificate is available
* Male or female child between 29 days and 1 year of age, at the time of death
* Post-neonatal LRTI-related death occurred during the study period
* Written informed consent is obtained from the parent/guardian/legal representative of the subject.
For a child to be included in the random sample selected from the IMSS dataset must meet the following criteria:
* Subject is an IMSS affiliate.
* Male or female child belonging to the annual birth cohort selected for the evaluation.
* Written informed consent is obtained from the parent/guardian/legal representative of the subject.
* Subject did not die.
* Subject currently lives in Mexico.
IS Cases Selected from IMSS Dataset must meet the following criteria:
* Subject with an IS identified in the IMSS dataset.
* Male or female child is \<1 year of age at the time of diagnosis of the IS (patient becomes ineligible on the day of their first birthday).
* Subject belongs to the annual birth cohort selected for the evaluation.
Children Selected as Controls for Matched Assessment
• subject matched to a case by gender, hospital of birth and date of birth as described above.
Exclusion Criteria:
For a child to be included as a matched control:
* subject is dead
* subject is not currently living in Mexico
* subject experienced an IS episode recorded in the IMSS database.
Exclusion criteria for enrollment: none
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Year
Study:
NCT00436358
Study Brief:
Protocol Section:
NCT00436358