Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Severe acute COVID-19 infection (SACI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Severe acute COVID-19 infection (SACI)
时间窗: Up to 16 weeks
The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
次要结局
- Treatment with vasopressor support(Up to 8 weeks)
- Administration of low-flow oxygen therapy via nasal cannula or face mask(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(Up to 12 weeks)
- Treatment with extracorporeal membrane oxygenation (ECMO)(Up to 8 weeks)
- Length of hospital stay(Up to 24 weeks)
- Treatment with mechanical ventilation(Up to 12 weeks)
- Length of ICU stay(Up to 16 weeks)
研究者
Itai Shavit
Chair, Division of Pediatrics, Hadassah Medical Center
Hadassah Medical Organization