Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
- Conditions
- COVID-19Inflammatory Response
- Interventions
- Diagnostic Test: Nasopharyngeal swab sampling for COVID-19
- Registration Number
- NCT06434701
- Lead Sponsor
- Hadassah Medical Organization
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
-
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
-
MIS-C Patients aged 16 years or younger diagnosed with MIS-C
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Severe acute COVID-19 infection Nasopharyngeal swab sampling for COVID-19 Nasopharyngeal swab sampling for COVID-19
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
Length of hospital stay Up to 24 weeks Mean duration of hospital stay for patients admitted with COVID-19
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
Length of ICU stay Up to 16 weeks Mean duration of ICU stay for patients admitted with COVID-19
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
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
Trial Locations
- Locations (6)
Haemek Medical Center
🇮🇱Afula, Israel
Soroka Medical Center
🇮🇱Be'er Sheva, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Sheba Medical Center
🇮🇱Tel HaShomer, Israel