Clinical trial NCT05421247: A Study on Children With COVID-19 Admitted at Assiut University Children Hospital
Official title: A Descriptive Study on Children With COVID-19 Admitted at Isolation Unit of Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: children
COVID-19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 98
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: to describe demographic and clinical data of children infected with COVID-19 admitted at isolation unit of Assiut university children hospital
timeFrame: Baseline
Secondary outcomes:
measure: to assess the risk factors responsible for complications of COVID-19 in children.
timeFrame: Baseline
measure: to assess the outcome of COVID-19 in children admitted at AUCH
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
name: Nagla H. Ibrahim, professor
role: STUDY_DIRECTOR
References:
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.
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):e20200702. doi: 10.1542/peds.2020-0702. Epub 2020 Mar 16.
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. No abstract available.
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. No abstract available.
citation: 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.
citation: [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.
citation: [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).
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. No abstract available.
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.