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.
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
- Conditions the study is for
- Assess the Outcome for Children With Covid-19 Admitted in Assuit University Children Hospital
- 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.
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.
- Conditions
- Assess the Outcome for Children With Covid-19 Admitted in Assuit University Children Hospital
- 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 group | Role | What they receive |
|---|---|---|
| mild cases | Not described | |
| moderate cases | Not described Receives: Diagnostic Test: RT PCR test of COVID 19 | |
| severe cases | Not 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.
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)
- 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.
- First posted11 Jul 2023
- Study start1 Apr 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess the Outcome for Children With Covid-19 Admitted in Assuit University Children HospitalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohamed Hussien, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Admission of Children With COVID-19 Admitted in Assuit University Children Hospital.
- ClinicalTrials.gov ID
- NCT05940155
- Acronym / sponsor ID
- Diagnosis of COVID-19
- Conditions
- Assess the Outcome for Children With Covid-19 Admitted in Assuit University Children Hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild cases | – | – |
| moderate cases | – | Diagnostic Test: RT PCR test of COVID 19 |
| severe cases | – | Diagnostic Test: RT PCR test of COVID 19 |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All the patients from birth up to 18 years old admitted with suspectedor confirmed cases of covid-19 in AUCH.
Key exclusion criteria (1 listed)
- : Any patient not suspected or confirmed to have COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT PCR test of COVID 19diagnostic test by naso-pharyngel swab to confirm the diagnosis of covid-19 at moderate and severe cases. | Diagnostic test | moderate cases, severe cases |
Primary outcome
Evaluate pattern of admission of children with covid-19 admitted in Assuit University Children Hospital.
Time frame: one year
Evaluate pattern of admission of children with covid-19 admitted in Assuit University Children Hospital.
1 secondary outcome
- Assess the outcome for children with covid-19 admitted in Assuit University Children Hospital
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.