COVID-19, Inflammatory Response
Conditions
Brief summary
Even though the COVID-19 pandemic is no longer at its peak, the threat still lingers. Engaging in prospective surveillance studies will enable us to monitor the disease and prepare for any potential resurgence. COVID-19 surveillance studies are essential tools for policymakers to make informed decisions, allocate resources, and develop strategies to control the spread of the virus and protect public health. The objective of this surveillance study is to prospectively assess in-hospital severe morbidity related to COVID-19 infection in children who present to the Pediatric Emergency Department (ED). A prospective multicenter study will be conducted across eight EDs in Israel and five EDs in the United Kingdom. The study population will include children aged 16 years or younger with a severe acute COVID-19 infection. Confirmation of acute COVID-19 infection will be based on polymerase chain reaction nasopharyngeal swab testing. The study will also include patients diagnosed with multisystem inflammatory syndrome in children (MIS-C), as defined by the CDC.
Interventions
DIAGNOSTIC_TESTNasopharyngeal swab sampling for COVID-19
The healthcare provider will gently insert the swab a short distance (1-1.5 cm for young children) into one nostril, reaching the back of the nasal cavity. The swab will then be gently rotated and rubbed for a few seconds to collect a sample of mucus. The same process may be repeated in the other nostril.
Sponsors
London North West Healthcare NHS Trust
Hadassah Medical Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. SACI Patients aged 16 years or younger with a positive COVID-19 PCR nasopharyngeal swab testing or bronchoalveolar sample who meet the definition of SACI: * Receive oxygen via low-flow nasal cannula or oxygen mask, high-flow nasal cannula, bilevel or continuous positive airway pressure machine, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) Or * Admitted to ICU 2. MIS-C Patients aged 16 years or younger diagnosed with MIS-C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe acute COVID-19 infection (SACI) | Up to 16 weeks | The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Administration of high-flow oxygen via nasal cannula (HFNC), or administration of oxygen via bilevel or continuous positive airway pressure (CPAP) machine | Up to 12 weeks | The percentage of COVID-19 patients treated with HFNC or CPAP among all patients admitted to the Emergency Department |
| Treatment with mechanical ventilation | Up to 12 weeks | The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department |
| Treatment with extracorporeal membrane oxygenation (ECMO) | Up to 8 weeks | The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department |
| Administration of low-flow oxygen therapy via nasal cannula or face mask | Up to 12 weeks | The percentage of COVID-19 patients treated with low-flow oxygen among all patients admitted to the Emergency Department |
| Length of ICU stay | Up to 16 weeks | Mean duration of ICU stay for patients admitted with COVID-19 |
| Length of hospital stay | Up to 24 weeks | Mean duration of hospital stay for patients admitted with COVID-19 |
| Treatment with vasopressor support | Up to 8 weeks | The percentage of COVID-19 patients treated with vasopressor support among all patients admitted to the Emergency Department |
Countries
Israel
Contacts
Primary ContactItai Shavit, MD
Backup ContactHadas Lamberg, PhD
Outcome results
None listed