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:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT05239104
Eligibility Criteria:
Inclusion Criteria:
* Child is aged between 1 month -14 years 11 months at the time of admission/presentation to outpatient / ED / hospital
* Child presents to or is admitted to hospital at one of the participating study site hospitals within the time period of the study
* Child presents with symptoms of acute illness that started within the last 2 weeks (14 days) prior to hospital presentation. This will include children with a chronic illness but with new onset of symptoms within last 2 weeks.
* Child is assessed by a health officer at the participating study site hospital and is deemed to have a "severe" illness/injury. A "severe" illness/injury will be defined as a child showing any emergency signs as outlined in the WHO Pocketbook, second edition:
OR Requires hospital admission/transfer to another health facility for further investigations and/or treatment for their acute illness/injury that cannot be performed in an outpatient setting or ED. This may include but is not limited to: transfer to another hospital with intensive care unit (ICU), intravenous (IV) medication or fluids; enteral nutrition; oxygen therapy; surgery.
• Parent/guardian has provided written informed consent, and will be available for the duration of the study follow-up period.
Exclusion Criteria:
* Child \<1 month or \>14 years 11 months at time of presentation to hospital
* Child with symptoms that started \>2 weeks (\>14 days) prior to hospital presentation
* Child admitted to the neonatal intensive care unit (NICU)
* Child admitted to hospital for a planned procedure or planned treatment of a chronic medical condition (eg. Tonsillectomy, replacement of ventriculoperitoneal shunt or percutaneous endoscopic gastronomy (PEG) tube, tune up for cystic fibrosis, chemotherapy, palliative care),
* Child already enrolled into this study from a previous hospital admission
* Child discharged prior to screening and informed consent processes by study team members.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
15 Years
Study:
NCT05239104
Study Brief:
Protocol Section:
NCT05239104