Hematology and Clinical Picture in Pediatric COVID-19 Infection

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487119
• Other study ID #: RC 6-7-2020
• Status: Completed
• Start date: August 12, 2020
• Est. completion date: August 23, 2020

Study information

• Verified date: September 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 23, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Infection

Locations

Country	Name	City	State
Egypt	Benha Faculty of Medicine	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Fan BE, Chong VCL, Chan SSW, Lim GH, Lim KGE, Tan GB, Mucheli SS, Kuperan P, Ong KH. Hematologic parameters in patients with COVID-19 infection. Am J Hematol. 2020 Jun;95(6):E131-E134. doi: 10.1002/ajh.25774. Epub 2020 Mar 19. — View Citation

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematological findings	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	clinical presentations	proportion of patients with respiratory and GIT symptoms, proportion of patients needs ICU admission relation between severity and hematologic indices	at time of admission