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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05421247
Collaborator
(none)
98
21

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    98 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    A Descriptive Study on Children With COVID-19 Admitted at Isolation Unit of Assiut University Children Hospital
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Nagla H. Ibrahim, professor,

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Yasser Mohamed Abd Elaal Ahmed, resident at Assiut University Children Hospital, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05421247
    Other Study ID Numbers:
    • COVID-19 in children
    First Posted:
    Jun 16, 2022
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yasser Mohamed Abd Elaal Ahmed, resident at Assiut University Children Hospital, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022