Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection
Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection: a Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design and participants A prospective multicenter study was designed. It was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Informed consent was obtained for all participants. From April 8, 2022 to May 17, 2022, Patients who attended the child-parent sections of the Fangcang shelter hospitals in Shanghai, China, with laboratory-confirmed COVID-19 were included. Those who had poor compliance (defined as inability to comply with the protocol) were excluded. Data from the included cases were collected. Adult patients and caregivers of children patients received two kinds of questionnaires after admission. Type I questionnaire (supplemental material) for basic characteristic were finished as soon as they were admitted. Type II questionnaire (supplemental material) for symptom and medication use tracking were filled out every day until discharge. This study was approved by the ethics committee of Shanghai Children's Medical Center.
Definition of outcomes The outcomes were the likelihood of developing prolonged fever and the likelihood of developing high fever. Fever was defined as temperature ≥ 38.0℃. Prolonged fever was defined as fever for more than 2 days. High fever was defined as temperature ≥ 39.1℃.
Statistical analysis SPSS version 25.0 (IBM SPSS Statistics, Armonk, NY, USA) was used to analyze the data. Data are presented as median values and interquartile ranges (IQRs) for continuous variables and frequencies and percentages for categorical variables. The investigators used Mann-Whitney U test to compare continuous variables between two groups. The investigators used χ2 test or Fisher exact test to compare categorical variables. Univariable analysis was used to investigate the association of each clinical variable with the outcomes. To determine the risk factors for each outcome, multivariable analysis was performed by logistic regression with a stepwise variable model. Variables of P value < 0.05 were candidates for multivariable analysis. Statistical significance was determined as a 2-sided P value of < 0.05.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai, China
- child-parent sections of the Fangcang shelter hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- hospitalized in the child-parent sections of the Fangcang shelter hospitals in Shanghai, China
- diagnosis of laboratory-confirmed COVID-19
Exclusion Criteria:
● have poor compliance (defined as inability to comply with the protocol)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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pediatric patients
pediatric patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19
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Patient data were collected from questionnaires.
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adult patients
adult patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19
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Patient data were collected from questionnaires.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants with prolonged fever or high fever
Time Frame: From April 8, 2022 to May 17, 2022
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Fever's defined as temperature ≥ 38.0℃.
Prolonged fever's defined as fever for more than 2 days.
High fever's defined as temperature ≥ 39.1℃.
Questionnaires for basic characteristic're finished as soon as they're admitted.
Questionnaires for symptom and medication use tracking're filled out every day until discharge.
The risk factors for prolonged fever and high fever're identified by univariate and multivariate analyses.
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From April 8, 2022 to May 17, 2022
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCMCIRB-K2022040-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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