Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nasopharyngeal swab sampling for COVID-19.
- Who it may be relevant to
- Registry conditions: COVID-19, Inflammatory Response. Basic parameters: 0 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
Overview
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 test Nasopharyngeal 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.
Primary outcome measures
- Severe acute COVID-19 infection (SACI) [Time frame: Up to 16 weeks]
Secondary outcome measures (7)
- Administration of low-flow oxygen therapy via nasal cannula or face mask [Time frame: Up to 12 weeks]
- Administration of high-flow oxygen via nasal cannula (HFNC), or administration of oxygen via bilevel or continuous positive airway pressure (CPAP) machine [Time frame: Up to 12 weeks]
- Treatment with mechanical ventilation [Time frame: Up to 12 weeks]
- Treatment with extracorporeal membrane oxygenation (ECMO) [Time frame: Up to 8 weeks]
- Treatment with vasopressor support [Time frame: Up to 8 weeks]
- Length of ICU stay [Time frame: Up to 16 weeks]
- Length of hospital stay [Time frame: Up to 24 weeks]
Eligibility criteria
Inclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Israel · 6 centers
- Haemek Medical Center — Afula
- Soroka Medical Center — Beersheba
- Hadassah Medical Center — Jerusalem
- Shaare Zedek Medical Center — Jerusalem
- Meir Medical Center — Kfar Saba
- Sheba Medical Center — Tel Litwinsky
Identifiers
NCT: NCT06434701 · SPICE-HMO-CTIL