Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463821
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2024-06-11
Brief Title:
Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection
Sponsor:
Shanghai Childrens Medical Center
Organization:
Shanghai Childrens Medical Center
Study Overview
Official Title:
Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection a Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The omicron variant of coronavirus disease 2019 COVID-19 has caused a global epidemic in 2022 The aim was to investigate the symptom spectrum and risk factors for fever in pediatric and adult patients with omicron infection From April 8 2022 to May 17 2022 this prospective observational study included patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19 Patient data were collected from questionnaires The risk factors for prolonged fever and high fever were identified by univariate and multivariate analyses
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 Childrens 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 380 Prolonged fever was defined as fever for more than 2 days High fever was defined as temperature 391
Statistical analysis SPSS version 250 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 005 were candidates for multivariable analysis Statistical significance was determined as a 2-sided P value of 005
Definition of outcomes The outcomes were the likelihood of developing prolonged fever and the likelihood of developing high fever Fever was defined as temperature 380 Prolonged fever was defined as fever for more than 2 days High fever was defined as temperature 391
Statistical analysis SPSS version 250 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 005 were candidates for multivariable analysis Statistical significance was determined as a 2-sided P value of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None