Hematology and Clinical Picture in Pediatric COVID-19 Infection

September 6, 2020 updated by: Shaimaa Reda Abdelmaksoud, Benha University

Pediatric COVID-19 Infection; Do Clinical Features and Hematological Parameters Predict the Need for ICU Admission?

This study is to discuss the different clinical presentations, hematological and laboratory abnormalities in pediatric COVID-19 infection.

Study Overview

Status

Completed

Conditions

Detailed Description

This retrospective observational study will be conducted at Benha University Hospital, Benha, Egypt; after approval by the local ethical committee of Faculty of Medicine, Benha University, Egypt.

We will include in this retrospective study all pediatric patients who were admitted with confirmed COVID-19 infection with age range from birth to 18 years during the period from April 2020 till July 2020. The diagnosis of COVID-19 infection is based on positive SARS-CoV-2 RNA detection in throat swab specimens by PCR.

All data including demography information, contact history, previous history, clinical symptoms, clinical examination on admission, and hematology and laboratory information will be obtained from inpatient medical records.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalubia
      • Banhā, Qalubia, Egypt
        • benha faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all pediatric patients who were admitted with confirmed COVID-19 infection with age range from birth to 18 years during the period from April 2020 till July 2020. The diagnosis of COVID-19 infection is based on positive SARS-CoV-2 RNA detection in throat swab specimens by PCR.

Description

Inclusion Criteria:

-inpatient confirmed COVID-19 infection by PCR

Exclusion Criteria:

  • patients with records missing hematology and/or laboratory data,
  • patients transfered to other medical facilities with unknown outcomes,
  • patients with age older than 18 years from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematological findings
Time Frame: at time of admission
hematological indices; TLC, absolute lymphocytic count, absolute neutrophil count platelet count, N/L ratio and CRP in pediatric COVID-19 infection
at time of admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical presentations
Time Frame: at time of admission
proportion of patients with respiratory and GIT symptoms, proportion of patients needs ICU admission relation between severity and hematologic indices
at time of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Shaimaa R Abdelmaksoud, MD, benha faculty of medicine
  • Study Chair: Rana A Khashaba, MD, benha faculty of medicine
  • Study Chair: Effat H Assar, MD, benha faculty of medicine
  • Study Chair: Rasha S Eldesouky, MD, benha faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 12, 2020

Primary Completion (ACTUAL)

August 20, 2020

Study Completion (ACTUAL)

August 23, 2020

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (ACTUAL)

July 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 6, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 6-7-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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