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NCT06434701 | RECRUITING | COVID-19

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

Hadassah Medical Organization

Information provided by (Responsible Party):

digital power

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.

Condition or disease

COVID-19

Inflammatory Response

Intervention/treatment

Nasopharyngeal swab sampling for COVID-19

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 500 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
Actual Study Start Date : 2024-09-30
Estimated Primary Completion Date : 2026-08-31
Estimated Study Completion Date : 2026-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 16 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Severe COVID-19 Infection in Children Presenting to EDs in Israel and England

Location Details

NCT06434701

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Israel,

Haemek Medical Center

Afula, Israel,

RECRUITING

Israel,

Soroka Medical Center

Beersheba, Israel,

RECRUITING

Israel,

Hadassah Medical Center

Jerusalem, Israel,

RECRUITING

Israel,

Shaare Zedek Medical Center

Jerusalem, Israel,

RECRUITING

Israel,

Meir Medical Center

Kfar Saba, Israel,

RECRUITING

Israel,

Sheba Medical Center

Tel Litwinsky, Israel,