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OpenTrials
Completed

NCT Number: NCT04404244

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

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, 11566, Egypt

About this study

Study Procedures:

On admission or during the outpatient visit:

  • Obtaining an informed consent .
  • Full medical history, concurrent medications, demographic data and epidemiological data (history of contact to a COVID-19 case, history of travel), will be obtained.
  • A thorough physical examination will be performed.
  • Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and blood oxygen saturation) will be recorded.
  • 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:

  • Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if indicated will be collected
  • Chest X-ray or CT chest will be recorded.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children below 18 years with malignancy either hematological or solid tumors or
  • Children below 18 years with hematological condition

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Incidence of COVID-19 among children with cancer

    Time frame: 12 months

    Measure the incidence of COVID-19 infection among children with cancer

Secondary outcomes

  1. Families training

    Time frame: 12 months

    Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission

Sponsors and collaborators

Lead sponsor

Fatma Soliman Elsayed Ebeid, MD

Other

Registry information

Acronym: PedCan-COVID

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 27, 2020
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.