Monitoring severe COVID-19 infections in children in Israel and England
Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
This study is trying to track how severe COVID-19 affects children under 16 in emergency departments in Israel and the UK to better understand the illness and its complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 0 Years to 16 Years |
| Sex | All |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 6 sites (Afula and 5 other locations) |
| Trial ID | NCT06434701 on ClinicalTrials.gov |
What this trial studies
This study aims to conduct prospective surveillance of severe morbidity related to COVID-19 infection in children presenting to Pediatric Emergency Departments in Israel and the UK. It will involve a multicenter approach across multiple hospitals, focusing on children aged 16 years or younger who have a confirmed acute COVID-19 infection. The confirmation will be based on polymerase chain reaction testing of nasopharyngeal swabs. The study will also include patients diagnosed with multisystem inflammatory syndrome in children (MIS-C).
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 16 years or younger with severe acute COVID-19 infection or diagnosed with MIS-C.
Not a fit: Patients who do not have severe COVID-19 infection or MIS-C, or those older than 16 years, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the management and outcomes of severe COVID-19 infections in children, aiding in better healthcare strategies.
How similar studies have performed: Other studies have shown the importance of surveillance in managing COVID-19, but this specific multicenter approach in children is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Afula and 5 other locations
- Haemek Medical Center — Afula, Israel (Recruiting)
- Soroka Medical Center — Beersheba, Israel (Recruiting)
- Hadassah Medical Center — Jerusalem, Israel (Recruiting)
- Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
- Meir Medical Center — Kfar Saba, Israel (Recruiting)
- Sheba Medical Center — Tel Litwinsky, Israel (Recruiting)
Study contacts
- Study coordinator: Itai Shavit, MD
- Email: shavit1@hadassah.org.il
- Phone: 00 972 50 2063239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.