Clinical trial NCT04487119: Hematology and Clinical Picture in Pediatric COVID-19 Infection
Official title: Pediatric COVID-19 Infection; Do Clinical Features and Hematological Parameters Predict the Need for ICU Admission?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID19
hematology
pediatric
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 29
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: hematological findings
timeFrame: at time of admission
Secondary outcomes:
measure: clinical presentations
timeFrame: at time of admission
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha Faculty of Medicine
state: Qalubia
Study officials:
affiliation: Benha University
name: Shaimaa R Abdelmaksoud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Rana A Khashaba, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Effat H Assar, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Rasha S Eldesouky, MD
role: STUDY_CHAIR
References:
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 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
citation: 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. No abstract available.