RecruitingNot ApplicableNCT06434701

Severe COVID-19 Infection in Children Presenting to EDs in Israel and England

Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study


Sponsor

Hadassah Medical Organization

Enrollment

500 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 YearsMax Age: 16 Years

Inclusion Criteria5

  • 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

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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.


Locations(6)

Haemek Medical Center

Afula, Israel

Soroka Medical Center

Beersheba, Israel

Hadassah Medical Center

Jerusalem, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Sheba Medical Center

Tel Litwinsky, Israel

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NCT06434701


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