Clinical trial NCT05767294: Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan
Official title: Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: RSV Infection
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China

Brief summary: The study will be a multicenter, hospital-based retrospective study. We plan to collect the clinical and laboratory data among all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China.


Eligibility criteria: Inclusion Criteria:

①Admission age \<5 years old

②Clinical diagnosis of acute respiratory tract infections

Exclusion Criteria:

Hospital acquired ARTI

Primary outcomes:
measure: number of patients with fever
timeFrame: at admission
measure: number of patients with cough
timeFrame: at admission
measure: number of patients with shortness of breath
timeFrame: at admission
measure: number of patients with shortness of wheeze
timeFrame: at admission
measure: number of patients with shortness of vomit
timeFrame: at admission
measure: number of patients with shortness of rale
timeFrame: at admission
measure: number of patients with shortness of stridor
timeFrame: at admission
measure: age
timeFrame: at admission
measure: gender
timeFrame: at admission
measure: number of patients with underlying disease
timeFrame: at admission
measure: Imaging examination results
timeFrame: through study completion, an average of 1 year
measure: length of hospital stay length of stay length of stay
timeFrame: through study completion, an average of 1 year
measure: number of patients with treatment of antibiotic
timeFrame: through study completion, an average of 1 year
measure: number of patients with treatment of immunoglobulin
timeFrame: through study completion, an average of 1 year
measure: number of patients with treatment of glucocorticoids
timeFrame: through study completion, an average of 1 year
measure: number of patients with treatment of oxygen inhalation
timeFrame: through study completion, an average of 1 year
measure: number of patients with treatment of ventilation
timeFrame: through study completion, an average of 1 year
measure: direct medical cost
timeFrame: through study completion, an average of 1 year
measure: proportion of different virus genotype
timeFrame: through study completion, an average of 1 year
measure: F protein gene sequence
timeFrame: through study completion, an average of 1 year
measure: number of patients infected with bacteria
timeFrame: through study completion, an average of 1 year
measure: number of patients infected with virus
timeFrame: through study completion, an average of 1 year
measure: number of patients infected with fungus
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: department of pediatrics, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: