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

COVID-19 Clinical Trial

Official title:

A Descriptive Study on Children With COVID-19 Admitted at Isolation Unit of Assiut University Children Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05421247
• Other study ID #: COVID-19 in children
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: June 2024

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: Yasser M. Abd Elaal
• Phone: 01021356722
• Email: yasser.mohamed412[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

[6] Masoud H, Elassal G, Zaky S, Baki A, Ibrahim H, Amin W, et al. Management Protocol for COVID-19 Patients Version 1.4/30th May 2020 Ministry of health and population (MOHP), Egypt. 2020.

[7] Mostafa A, Abdalbaky A, Fouda E, Shaaban H, Elnady H, Hassab-Allah M et al. Practical approach to COVID-19: an Egyptian pediatric consensus. Egyptian Pediatric Association Gazette. 2020;68(1).

CDC COVID-19 Response Team. Coronavirus Disease 2019 in Children - United States, February 12-April 2, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 10;69(14):422-426. doi: 10.15585/mmwr.mm6914e4. — View Citation

Chen ZM, Fu JF, Shu Q, Chen YH, Hua CZ, Li FB, Lin R, Tang LF, Wang TL, Wang W, Wang YS, Xu WZ, Yang ZH, Ye S, Yuan TM, Zhang CM, Zhang YY. Diagnosis and treatment recommendations for pediatric respiratory infection caused by the 2019 novel coronavirus. World J Pediatr. 2020 Jun;16(3):240-246. doi: 10.1007/s12519-020-00345-5. Epub 2020 Feb 5. Review. — View Citation

Dong Y, Mo X, Hu Y, Qi X, Jiang F, Jiang Z, Tong S. Epidemiology of COVID-19 Among Children in China. Pediatrics. 2020 Jun;145(6). pii: e20200702. doi: 10.1542/peds.2020-0702. Epub 2020 Mar 16. — View Citation

Klein JD, Koletzko B, El-Shabrawi MH, Hadjipanayis A, Thacker N, Bhutta Z. Promoting and supporting children's health and healthcare during COVID-19 - International Paediatric Association Position Statement. Arch Dis Child. 2020 Jul;105(7):620-624. doi: 10.1136/archdischild-2020-319370. Epub 2020 May 7. — View Citation

Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29. — View Citation

Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. — View Citation

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to describe demographic and clinical data of children infected with COVID-19 admitted at isolation unit of Assiut university children hospital	to describe demographic data (age ,sex ,residence , socioeconomics,...etc.) and length of hospital stay	Baseline
Secondary	to assess the risk factors responsible for complications of COVID-19 in children.	History of contact with patients positive for COVID-19, If associated comorbidities for example DM, immune deficiency and chronic kidney disease	Baseline
Secondary	to assess the outcome of COVID-19 in children admitted at AUCH	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	Baseline

External Links

•   [9] Centers for Disease Control and Prevention. 2021. Healthcare Workers. [online] Available at: <https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html> [Accessed 19 October 2021].