to Contribute to a Better Control of COVID-19 in Children in NigerNCT05886179
COVID-19 IN CHILDREN IN NIGER, 2020
An observational study of to Contribute to a Better Control of COVID-19 in Children in Niger, run by Centre de Recherche Médicale et Sanitaire at 1 site in Niger.
Trial summary
On January 30, 2020, the WHO declared COVID-19 a global health emergency. Children were affected with less severe forms. Niger had implemented measures in a context where children are a source of contamination. Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- to Contribute to a Better Control of COVID-19 in Children in Niger
- What is being tested?
- cross-sectional study
- How many people
- 572 participants
- Where
- 1 siteNiger
- Study dates
- 25 Feb 2020to 15 Jan 2021
- 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 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: This was an analytical cross-sectional study with retrospective collection of epidemiological surveillance data on COVID-19 in Niger. The study period spanned six (6) months from February 25 to August 28, 2020. Children aged 0-15 years suspected of having COVID-19 whose data were in the DSRE database were included. We used the data extraction form that served as a secondary database containing only our variables of interest.
Who may be able to join
- Children aged 0-15 years suspected of having COVID-19 whose data were in the DSRE database were included
Who cannot join
- Children whose data is not complete
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With COVID-19 in Children Aged 0-15 Years in Niger, 2020
On January 30, 2020, the WHO declared COVID-19 a global health emergency. Children were affected with less severe forms. Niger had implemented measures in a context where children are a source of contamination. The objective was to determine the factors associated with COVID-19 in children in Niger from February to August 2020 through an analysis of the national database.
Read the detailed description
We conducted an analytical cross-sectional study including all COVID-19 suspects in the database. We used Excel and Epi Info 7.2.4. software for data extraction and analysis. Frequencies and proportions were calculated, we estimated in a logistic regression the OR of association with their 95% confidence interval, the factors associated with COVID-19 at the threshold of p<0.05.
Results: Of 572 notified suspected COVID-19 cases in children aged 0-15 years, 11.36% were positive. The median age of infected children was 10 years [IQR: 5- 13 years]. The sex ratio of males to females was 2.1. Children aged 11-15 years were 49.2%, 61.5% resided in Niamey, 4.6% had comorbidities. The notion of travel was 12.3% and 40% had a notion of contact, 24.4% had a fever, 23.2% had a cough, 18% were hospitalized and the case fatality was 1.5%. In etiological analysis, the factors associated with COVID-19 were sex ORa= 0.51 [0.28-0.93] p=0.028, the presence of symptoms ORa= 2.29 [1.23-4.25] p=0.008 and the notion of contact ORa= 0.32 [0.13-0.77] p=0.011.
exposed children were sensitive to COVID-19, all age groups were affected with a male predominance. We recommend barrier measures adapted to young people, early detection and management of infected children.
- Being tested
- cross-sectional study
- Keywords
- factors, COVID-19, children, database, Niger
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectional studyOther
analytical cross-sectional study with retrospective collection of epidemiological surveillance data on COVID-19 in Niger.
What is being measured
The primary outcome is the main question the study is designed to answer.
data base analysis
The first step concerned the descriptive part where the frequencies, proportions, means and extreme values of the variables were calculated. Some of these variables were presented in the form of tables and graphs.
Measured: May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start25 Feb 2020
- Primary completion28 Aug 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Contribute to a Better Control of COVID-19 in Children in NigerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale et Sanitaire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IDE AMADOU Habibatou, Centre de Recherche Médicale et Sanitaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886179
- Sponsor's protocol ID
- CERMES
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: What is IPD ?
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With COVID-19 in Children Aged 0-15 Years in Niger, 2020
- ClinicalTrials.gov ID
- NCT05886179
- Acronym / sponsor ID
- CERMES
- Keywords
- factors, COVID-19, children, database, Niger
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Centre de Recherche Médicale et SanitaireUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 2 Jun 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.
On January 30, 2020, the WHO declared COVID-19 a global health emergency. Children were affected with less severe forms. Niger had implemented measures in a context where children are a source of contamination. The objective was to determine the factors associated with COVID-19 in children in Niger from February to August 2020 through an analysis of the national database.
Detailed description
We conducted an analytical cross-sectional study including all COVID-19 suspects in the database. We used Excel and Epi Info 7.2.4. software for data extraction and analysis. Frequencies and proportions were calculated, we estimated in a logistic regression the OR of association with their 95% confidence interval, the factors associated with COVID-19 at the threshold of p<0.05.
Results: Of 572 notified suspected COVID-19 cases in children aged 0-15 years, 11.36% were positive. The median age of infected children was 10 years [IQR: 5- 13 years]. The sex ratio of males to females was 2.1. Children aged 11-15 years were 49.2%, 61.5% resided in Niamey, 4.6% had comorbidities. The notion of travel was 12.3% and 40% had a notion of contact, 24.4% had a fever, 23.2% had a cough, 18% were hospitalized and the case fatality was 1.5%. In etiological analysis, the factors associated with COVID-19 were sex ORa= 0.51 [0.28-0.93] p=0.028, the presence of symptoms ORa= 2.29 [1.23-4.25] p=0.008 and the notion of contact ORa= 0.32 [0.13-0.77] p=0.011.
exposed children were sensitive to COVID-19, all age groups were affected with a male predominance. We recommend barrier measures adapted to young people, early detection and management of infected children.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This was an analytical cross-sectional study with retrospective collection of epidemiological surveillance data on COVID-19 in Niger. The study period spanned six (6) months from February 25 to August 28, 2020. Children aged 0-15 years suspected of having COVID-19 whose data were in the DSRE database were included. We used the data extraction form that served as a secondary database containing only our variables of interest.
Key inclusion criteria (1 listed)
- Children aged 0-15 years suspected of having COVID-19 whose data were in the DSRE database were included
Key exclusion criteria (1 listed)
- Children whose data is not complete
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 |
|---|---|---|
| cross-sectional studyanalytical cross-sectional study with retrospective collection of epidemiological surveillance data on COVID-19 in Niger. | Other | – |
Primary outcome
data base analysis
Time frame: May 2021
The first step concerned the descriptive part where the frequencies, proportions, means and extreme values of the variables were calculated. Some of these variables were presented in the form of tables and graphs.
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 2 Jun 2023.
- Individual participant dataSharing planned: No. What is IPD ?
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 to Contribute to a Better Control of COVID-19 in Children in Niger, run by Centre de Recherche Médicale et Sanitaire at 1 site in Niger.
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 2 Jun 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 Niger. 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?
data base analysis (time frame: May 2021). 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 2 Jun 2023.