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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Severe acute COVID-19 infection (SACI) [Срок оценки: Up to 16 weeks]

Вторичные конечные точки (7)

• Administration of low-flow oxygen therapy via nasal cannula or face mask [Срок оценки: 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 [Срок оценки: Up to 12 weeks]
• Treatment with mechanical ventilation [Срок оценки: Up to 12 weeks]
• Treatment with extracorporeal membrane oxygenation (ECMO) [Срок оценки: Up to 8 weeks]
• Treatment with vasopressor support [Срок оценки: Up to 8 weeks]
• Length of ICU stay [Срок оценки: Up to 16 weeks]
• Length of hospital stay [Срок оценки: Up to 24 weeks]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Израиль · 6 центров

• 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

Идентификаторы

NCT: NCT06434701 · SPICE-HMO-CTIL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗