A Study on Children With COVID-19 Admitted at Assiut University Children Hospital

• Conditions: COVID-19

• Registration Number: NCT05421247
• Lead Sponsor: Assiut University

Brief Summary

The aim of study is to: 1-describe demographic and clinical data of children infected with COVID-19 admitted at isolation unit of Assiut university children hospital 2- assess the risk factors responsible for complications of COVID-19 in children 3-assess the outcome of COVID-19 in children admitted at AUCH.

Detailed Description

In December 2019, reports emerged of a cluster of cases of pneumonia of unknown cause in Wuhan, China, culminating in the identification of a novel coronavirus on 12 January 2020, denoted as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2), and the associated disease as coronavirus disease 2019 (COVID-19) (1).

Some cases of infection in children have also been reported (2) the symptoms of pediatric COVID-19 are mild, the decrease in lymphocytes is not obvious and severe cases are rare. Initially, children comprised between 1% and 2% of the laboratory-confirmed SARSCoV-2 detections among people in China (3), Italy (4), and the United States (5). Initial reports from (CDC) noted the following age distributions: 15-17 years (32%), 10-14 years (27%), 5-9 years (15%), 1-4 years (11%), and \<1 year (15%), with a median age of 11 years (5).

Diagnosis of COVID-19 will depend on the clinical presentation of the case and on laboratory test as well as radiological finding. The cases will be stratified according to these collective data to different grades of severity (6). Investigations for suspected case: CBC and radiology, to confirm diagnosis: Nasopharyngeal swab for PCR and to assess severity: Serum ferritin, D dimer, LDH, and CRP. (7) Current treatment for COVID-19 is mainly supportive care (8).The decision of the site of management either at home or in hospital depends on the clinical presentation, requirement for supportive care, potential risk factors for severe disease, and the ability of the patient to self-isolate at home(9) (10).

Study Timeline

• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09
• Study Start: 2022-09
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• All children (up to 18 years) diagnosed with COVID-19 admitted at Isolaton Unit of Assiut university children hospital through the period from 1st January 2021 to 31st December 2022

Exclusion Criteria

• Clinically suspected patients approved by CT chest and PCR not infected with COVID-19.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to describe demographic and clinical data of children infected with COVID-19 admitted at isolation unit of Assiut university children hospital	Baseline	to describe demographic data (age ,sex ,residence , socioeconomics,...etc.) and length of hospital stay

Secondary Outcome Measures

Name	Time	Method
to assess the outcome of COVID-19 in children admitted at AUCH	Baseline	to assess the number of cases with complete recovery , the number of deaths and the cases with different complications as respiratory failure , renal failure ...etc and normalization of lab. data as(lymphocytic count , D- dimer , CRP ) and CORAD staging on chest CT
to assess the risk factors responsible for complications of COVID-19 in children.	Baseline	History of contact with patients positive for COVID-19, If associated comorbidities for example DM, immune deficiency and chronic kidney disease