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临床试验/NCT05898529
NCT05898529招募中不适用

Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients

Salem Anaesthesia Pain Clinic1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
350
试验地点
1
主要终点
Antigen test positive result

研究概览

简要总结

Children infected with COVID-19 are mostly asymptomatic. There is a dearth of data on the epidemiology of COVID-19 in the pediatric population. This is a prospective observational clinical study of pediatric surgical patients. COVID-19 rapid antigen testing will be performed on pediatric patients.

详细描述

Children infected with COVID-19 are mostly asymptomatic or mildly symptomatic. Children may spread COVID-19 to the elderly, vulnerable patients and medical staff. There is a dearth of data on the epidemiology of COVID-19 in the pediatric surgical population. Rapid antigen detection tests for the diagnosis of COVID-19 are reliable, simple, fast, and inexpensive.

This is a prospective observational clinical study. The study population will include all consenting pediatric surgical patients, aged 2-17 years. Informed consent will be obtained from each patient and the legal guardian who agree to participate in the study. Nasopharyngeal swab specimens will be collected from anesthetized pediatric patients. COVID-19 rapid antigen testing will be performed according to the equipment manufacturer's instructions.

Data collection will include COVID-19 test result, nasal swab complication, patient demographics, surgical history, medical history, regular medications, COVID-19 symptoms, and COVID-19 exposure information. COVID-19 symptoms that will be recorded are cough, wheeze, nasal congestion, breathing difficulty, new loss of taste or smell, fever, chills, rigors, body aches, sore throat, nausea, and fatigue. COVID-19 exposure will be considered as being within 6 feet of a person with diagnosed COVID-19 infection in the previous 14 days.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • surgical patients aged 2-17 years
  • informed consent for surgery
  • no COVID-19 diagnosis in previous 6 months
  • no history of nasal bleeding
  • no history of coagulopathy.

排除标准

  • patient refusal of testing
  • difficulty in obtaining consent
  • COVID-19 diagnosis in recent 6 month
  • history of nasal bleeding
  • history of coagulopathy.

结局指标

主要结局

Antigen test positive result

时间窗: 1 day

COVID-19 antigen test positive

次要结局

未报告次要终点

研究者

发起方
Salem Anaesthesia Pain Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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