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Assess the Outcome for Children With Covid-19 Admitted in Assuit University Children HospitalNCT05940155

Pattern of Admission of Children With COVID-19 Admitted in Assuit University Children Hospital.

An observational study of Assess the Outcome for Children With Covid-19 Admitted in Assuit University Children Hospital, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A novel coronavirus was identified following a cluster of cases of pneumonia in Wuhan, China, in December 2019. It rapidly spread as an outbreak there. On the 23rd of January 2020, it was announced that the outbreak constituted apublic health emergency of international concern. Read more about this study

Who is it for?
Ages 1 day to 18 years
What is being tested?
RT PCR test of COVID 19
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Apr 2022to 31 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: All subjects that meet the selection criteria (suspectedor confirmed cases of covid-19) in the period from 1st April 2022 till 31th March 2023, examined and/or admitted in AUCH.

Who may be able to join

  • All the patients from birth up to 18 years old admitted with suspectedor confirmed cases of covid-19 in AUCH.

Who cannot join

  • : Any patient not suspected or confirmed to have COVID-19

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine and Surgery At Assiut Univesity

    Asyut, 71515

Other trials in Egypt

About this study

A novel coronavirus was identified following a cluster of cases of pneumonia in Wuhan, China, in December 2019. It rapidly spread as an outbreak there. On the 23rd of January 2020, it was announced that the outbreak constituted apublic health emergency of international concern. Few weeks later, virus spread was recorded worldwide and was announcedas a pandemic by WHO in March 11, 2020.Global spread included Egypt, and the first case was recorded inEgypt onFebruary 14, 2020.Diagnosis of COVID-19 depend on a case definition of suspected and confirmed case.

Implementation of case definition depend on the clinical presentation of the case and on laboratory test as well asradiological finding.The cases will be stratified according to these collective data to different grades of severity.

Read more

Mild cases are either asymptomatic or symptomatic with Leucopenia and/or lymphopenia with no radiological evidence of pneumonia (upper respiratory tract illness ± one of the following symptoms: fever < 38, cough,GIT symptoms, myalgia and/or arthralgia).

Moderate cases include patients with leucopenia and/or lymphopenia with clinical and radiological evidence of pneumonia, including fever > 38 °Cwith or without cough and tachypnea (respiratory rate > 60 breaths/min forinfants < 2 months, > 50 breaths/min for infants 2-12 months, > 40 breaths/min for children 1-4 years, > 30 breaths/min for children older than5 years old), and the condition may be associated by moderate to severe dehydration.

Cases are considered as severe and critically ill if any of the following is present: - O2 saturation ≤ 92% despite escalating O2 therapy to maximal allowed 6 L/min - O2 saturation ≤ 90 % at room air - If the patient in septic shock, confused or hemodynamically unstable despite fluid resuscitation - If respiratory manifestations are combined with other organ failure - Chest radiography > 50% lesion or progressive lesion within 24-48 hrs.

Children may play a major role in community-based viral transmission. Available data suggest that children may have more upper respiratory tract involvement (including nasopharyngeal carriage) rather than lower respiratory tract involvement.

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. Supportive treatment including sufficient fluid and calories intake, and additional oxygen supplementation should be used in the treatment of children infected with COVID-19. The aim is to prevent ARDS, organ failure, and secondary nosocomial infections. If bacterial infection is suspected, broad-spectrum antibiotics may be used.

Being tested
RT PCR test of COVID 19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RT PCR test of COVID 19Diagnostic test

    diagnostic test by naso-pharyngel swab to confirm the diagnosis of covid-19 at moderate and severe cases.

Study groups in NCT05940155
Study groupRoleWhat they receive
mild casesNot described
moderate casesNot described
Receives: Diagnostic Test: RT PCR test of COVID 19
severe casesNot described
Receives: Diagnostic Test: RT PCR test of COVID 19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate pattern of admission of children with covid-19 admitted in Assuit University Children Hospital.

    Evaluate pattern of admission of children with covid-19 admitted in Assuit University Children Hospital.

    Measured: one year

Secondary outcomes (1)
  1. - Assess the outcome for children with covid-19 admitted in Assuit University Children Hospital

    • Assess the outcome for children with covid-19 admitted in Assuit University Children Hospital

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start1 Apr 2022
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05940155
Sponsor's protocol ID
Diagnosis of COVID-19
Status last verified
Jul 2023
First submitted
9 Jul 2023
Last updated
11 Jul 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Assess the Outcome for Children With Covid-19 Admitted in Assuit University Children Hospital, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate pattern of admission of children with covid-19 admitted in Assuit University Children Hospital. (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.

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