Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan

NCT05767294 | Enrolling By Invitation

• 1 other identifier: MISP-100898
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

RSV Infection

Outcome Measures

Primary Outcomes (23)

• number of patients with fever

  number of patients with fever

  at admission

• number of patients with cough

  number of patients with cough

  at admission

• number of patients with shortness of breath

  number of patients with shortness of breath

  at admission

• number of patients with shortness of wheeze

  number of patients with shortness of wheeze

  at admission

• number of patients with shortness of vomit

  number of patients with shortness of vomit

  at admission

• number of patients with shortness of rale

  number of patients with shortness of rale

  at admission

• number of patients with shortness of stridor

  number of patients with shortness of stridor

  at admission

• age

  age

  at admission

• gender

  female/male

  at admission

• number of patients with underlying disease

  underlying disease include immune deficiency, CHD, BPD, BO, bronchiectasis and asthma and so on

  at admission

• Imaging examination results

  X-Ray/CT

  through study completion, an average of 1 year

• length of hospital stay length of stay length of stay

  length of hospital stay

  through study completion, an average of 1 year

• number of patients with treatment of antibiotic

  number of patients with treatment of antibiotic

  through study completion, an average of 1 year

• number of patients with treatment of immunoglobulin

  number of patients with treatment of immunoglobulin

  through study completion, an average of 1 year

• number of patients with treatment of glucocorticoids

  number of patients with treatment of glucocorticoids

  through study completion, an average of 1 year

• number of patients with treatment of oxygen inhalation

  number of patients with treatment of oxygen inhalation

  through study completion, an average of 1 year

• number of patients with treatment of ventilation

  number of patients with treatment of ventilation

  through study completion, an average of 1 year

• direct medical cost

  direct medical cost

  through study completion, an average of 1 year

• proportion of different virus genotype

  virus genotype include A, B and C

  through study completion, an average of 1 year

• F protein gene sequence

  F protein gene sequence

  through study completion, an average of 1 year

• number of patients infected with bacteria

  number of patients infected with bacteria

  through study completion, an average of 1 year

• number of patients infected with virus

  number of patients infected with virus

  through study completion, an average of 1 year

• number of patients infected with fungus

  number of patients infected with fungus

  through study completion, an average of 1 year

Study Arms (6)

Neonatal

Other: Observation

1-3 months old

Other: Observation

3-6 months old

Other: Observation

6 months-1 year old

Other: Observation

1-2 years old

Other: Observation

2-5 years old

Other: Observation

Interventions

Observation OTHER

clinical manifestation (body temperature, fever days before admission, cough, red throat/sore throat, runny nose, shortness of breath, wheezing, vomiting), physical signs (auscultation of lungs, X-ray results), length of stay, therapeutic measures (oxygen therapy, ICU admission, antibiotic therapy, etc.)

1-2 years old; 1-3 months old; 2-5 years old; 3-6 months old; 6 months-1 year old; Neonatal

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• ①Admission age \<5 years old
• ②Clinical diagnosis of acute respiratory tract infections

You may not qualify if:

• Hospital acquired ARTI

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

department of pediatrics, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tongji Hospital, Tongji Medical college, Huazhong University of Science & Technology

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 14, 2023
• Study Start: December 5, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

CN (1)