NCT Number: NCT06434701
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.
Interested in participating?
Request Info0 year–16 year
All sexes
Interventional
Not applicable
Haemek Medical Center, Afula, Israel
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients aged 16 years or younger with a positive COVID-19 PCR nasopharyngeal swab testing or bronchoalveolar sample who meet the definition of SACI:
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.
Time frame: Up to 16 weeks
The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
Time frame: Up to 12 weeks
The percentage of COVID-19 patients treated with low-flow oxygen among all patients admitted to the Emergency Department
Time frame: Up to 12 weeks
The percentage of COVID-19 patients treated with HFNC or CPAP among all patients admitted to the Emergency Department
Time frame: Up to 12 weeks
The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department
Time frame: Up to 8 weeks
The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department
Time frame: Up to 8 weeks
The percentage of COVID-19 patients treated with vasopressor support among all patients admitted to the Emergency Department
Time frame: Up to 16 weeks
Mean duration of ICU stay for patients admitted with COVID-19
Time frame: Up to 24 weeks
Mean duration of hospital stay for patients admitted with COVID-19
Contact information is provided by the study sponsor or research team.
Hadas Lamberg, PhD
CONTACT
Itai Shavit, MD
CONTACT
Hadassah Medical Organization
Other
Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
Acronym: SPICE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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