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The Relationship Between Covid-19 Infection in Pediatric Patients and Secondary Lymphoid Organs

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ClinicalTrials.gov Identifier: NCT04646525
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Merih Onal, Selcuk University

Study Description
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Brief Summary:
We aimed to find out whether the tonsils and nasal tissues of pediatric patients are the main factors that protects the children's immune system against COVID-19 infection.

Condition or disease Intervention/treatment
Covid19 Immune Deficiency Tonsillitis Tonsil Hypertrophy Adenoiditis Adenoid Hypertrophy Diagnostic Test: Physical examination

Detailed Description:
Since it is known that the tonsil and adenoid tissues that are known as a secondary lymphoid organ, which form the first line of defense, are more active in childhood than adults, especially in the childhood age group, and since it has been scientifically shown that patients diagnosed with COVID-19 infection in the pediatric age group overcome this disease lightly than adults, we aimed to reveal whether the defined tonsil and adenoid tissues are the main factors that protect the children's immune system against COVID-19 infection.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Relationship Between Mild Covid-19 Infection in Pediatric Patients and Protection of Secondary Lymphoid Organs
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Physical examination
    Pediatric patients diagnosed with COVID-19 and who have had infection will be examined, adenoid and tonsillar tissues will be evaluated in terms of hypertrophy, chronic, or recurrent infection.
    Other Name: Only the tonsil and adenoid tissues of the patients will be examined by physical examination, no intervention will be done

Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome of our study was the evaluation of pediatric patients diagnosed with COVID-19 and who had COVID-19 infection in terms of adenoid and tonsillar tissue hypertrophy and the presence of chronic or recurrent infection. [ Time Frame: 2020-2021 ]
    The structure of the tonsil and adenoid tissues will be examined by physical examination, and the presence of tonsil and adenoid hypertrophy, tonsillitis, and adenoiditis conditions will be identified. The severity of covid-19 will be determined according to the cases of patients with tonsil and adenoid tissue disorders, who are hospitalized in intensive care, have infiltration in the lungs, and receive oxygen support.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients between the ages of 1-16 diagnosed with Covid-19 will be examined by the ENT doctor in terms of tonsil and adenoid tissues after they overcome the active infection period and PCR tests turn negative.
Criteria

Inclusion Criteria:

  • Patients with COVID-19 infection.
  • Patients aged between 1-16 years
  • Patients whose PCR test becomes negative

Exclusion Criteria:

  • Patients with lymphoid tissue malignant disease
  • Patients with known lung disease
  • Patients with known systemic disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646525


Contacts
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Contact: Selcen Celik +9033222443963 etikselcuk@gmail.com

Locations
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Turkey
Selcuk University Recruiting
Konya, Selcuklu, Turkey, 42100
Contact: Selcen Celik       etikselcuk@gmail.com   
Principal Investigator: Merih Onal, M.D.         
Sponsors and Collaborators
Selcuk University
Investigators
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Principal Investigator: Merih Onal, Assist. Prof. Selcuk University
More Information
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Publications:

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Responsible Party: Merih Onal, Assistant Professor, Selcuk University
ClinicalTrials.gov Identifier: NCT04646525    
Other Study ID Numbers: 2020/480
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We plan to share our study data after completing collecting patient data and preparing the article about the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merih Onal, Selcuk University:
pediatric
covid19
İmmune system
Additional relevant MeSH terms:
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COVID-19
Tonsillitis
Immunologic Deficiency Syndromes
Hypertrophy
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathological Conditions, Anatomical
Immune System Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases