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临床试验/NCT02979626
NCT02979626已完成不适用

Evaluation of Moderate to Severe Influenza Disease in Children 6 Months to 8 Years in Colorado

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 1,478 人开始时间: 2017年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,478
试验地点
2
主要终点
Hospitalization

研究概览

简要总结

The purpose of this study was to determine whether moderate-severe endpoints (including high fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary complications) were predictive of hospitalization, intensive care admission, antibiotic use and other complications in children under 8 years of age.

详细描述

This prospective observational study aimed to determine the risk difference of hospitalization due to moderate to severe influenza compared with mild influenza among children aged 6 months to 8 years who were evaluated at Children's Hospital Colorado emergency department and urgent care during the 2016-2017 influenza season. In addition, the study intended to evaluate the risk difference for other health outcomes such as ICU admission, antibiotic and antiviral use, caregiver and child absenteeism and recurrent (>1) healthcare visits, and to compare the healthcare costs associated with management of moderate to severe versus mild influenza in children. Children who presented to Children's Hospital Colorado Emergency Department (ED) and urgent care affiliated sites (North Campus urgent care) with an influenza-like illness from December 2016 to April 2017 and during the 2016-2017 influenza season, were eligible for the study. Once enrolled in the study, the investigators collected respiratory samples (nasal swab specimens) for influenza testing by PCR, sociodemographic and clinical data including variables of interest outlined above, and followed the clinical outcome of these children for 14 days after their initial presentation. Some of the variables of interest the investigators collected are shown below.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Months 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 6 months to < 8 years
  • Presentation to one of the study sites with signs and symptoms of influenza-like illness (temperature of >37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion)
  • Parents or guardians agreeing and consenting to medical information release, respiratory specimen collection and testing, email/phone call follow up and collection of leftover blood samples obtained during routine clinical care
  • Patients seen during the 2016-2017 influenza season

排除标准

  • Respiratory symptom duration > 14 days
  • Nurse only visit
  • Enrollment in the study within prior 14 days

结局指标

主要结局

Hospitalization

时间窗: 0-14 days

Hospitalization within 14 days of influenza infection diagnosis

次要结局

  • Antibiotic Use(0-14 days)
  • ICU Admission(0-14 days)
  • Work Absenteeism(0-14 days)
  • Antiviral Use(0-14 days)
  • Recurrent Visits(0-14 days)
  • School Absenteeism(0-14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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