Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic

Completed

• Conditions: Coronavirus COVID-19

• Registration Number: NCT04404244
• Lead Sponsor: Fatma Soliman Elsayed Ebeid, MD

Brief Summary

This is a prospective follow-up non-intervention study that will be carried out at Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All followed-up children below 18 years with cancer during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited.

Detailed Description

Study Procedures:

On admission or during the outpatient visit:

1. Obtaining an informed consent .

2. Full medical history, concurrent medications, demographic data and epidemiological data (history of contact to a COVID-19 case, history of travel), will be obtained.

3. A thorough physical examination will be performed.

4. Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and blood oxygen saturation) will be recorded.

5. Laboratory to perform the following tests:

Complete blood count with differential counts, COVID -19 reverse Transcription Polymerase Chain Reaction (RT-PCR) test by nasopharyngeal swab.

During admission:

Whenever unexplained fever and or respiratory symptoms developed or whenever COVID19 suspected to have the following to be performed:

1. Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if indicated will be collected

2. Chest X-ray or CT chest will be recorded.

3. Laboratory to perform the following tests:

Complete blood count with differential counts,

COVID-19 RT-PCR test by oropharyngeal and nasopharyngeal swab:

C-reactive protein and serum ferritin level. Coagulation test; D. dimer, prothrombin time and INR. Routine bacteriological study, blood culture and other symptoms/signs based cultures will be recorded

On discharge:

* Date of discharge

* Period of admission

* Period of fever

* A thorough physical examination will be performed

* Record the outcome

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Primary Completion: 2023-11-01
• Status Verified: 2024-01
• Study Completion: 2024-01-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Children below 18 years with malignancy either hematological or solid tumors or
2. Children below 18 years with hematological condition

Exclusion Criteria

1. Patients or care-givers refusal to be enrolled in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of COVID-19 among children with cancer	12 months	Measure the incidence of COVID-19 infection among children with cancer

Secondary Outcome Measures

Name	Time	Method
Families training	12 months	Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center; 🇪🇬 Cairo, Non-US, Egypt