Number of Patients During the Studying PeriodNCT04668937
Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy Pediatric Emergency Services
An observational study of Number of Patients During the Studying Period and Reason for Consultation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The first period of COVID 19 Lockdown Measures (From 18 March to 11 may 2020) change the French people way of life and their medicine knowledges. A study which evaluates the Nancy's Pediatric emergencies population utilization during this time could detect pathological changes. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Number of Patients During the Studying Period, Reason for Consultation
- How many people
- 11,000 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2020to 30 Jun 2020
- 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 Up to 17 years
- All sexes
- Child
Study population: All children who came to the Nancy's Pediatric emergencies during the period of the 18 march to the 30 June 2019 and 2020
Who may be able to join
- children who are cared during the study period to the Nancy's pediatric emergencies
Who cannot join
- be more than 18 years old
- Not being seen by a doctor
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU Nancy's Pediatric Emergencies
Vandœuvre-lès-Nancy, Lorraine, 54500
About this study
Official title: Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy
The first period of COVID 19 Lockdown Measures (From 18 March to 11 may 2020) change the French people way of life and their medicine knowledges. A study which evaluates the Nancy's Pediatric emergencies population utilization during this time could detect pathological changes. The medical impact of Home Confinement will show an increase (trauma, maltreatment) or decrease (virus disease) of several pathology. The study aims to help clinicians to the children care if another time of Home Confinement happened. The main objective is to evaluate the behavioural changes and the reason consultation in Nancy's Pediatric Emergencies from 18 March to 30 June 2020 comparate to the same time in 2019. We will continue the search after the end of Home Confinement until 30 June 2020 to evaluate what happened just after.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children who came to the Nancy's Pediatric emergencies during the study period in 2019 | Not described | |
| Children who came to the Nancy's Pediatric emergencies during the study period in 2020 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient who came to Nancy's pediatric emergencies during the study period
Measured: from 18 March to 30 June 2019 and 2020
Reason of consultation during the study period
Measured: from 18 March to 30 June 2019 and 2020
Secondary outcomes (2)
Number of children who was send by a General practician
Measured: from 18 March to 30 June 2019 and 2020
Medical reason to be sending by a General practician
Measured: from 18 March to 30 June 2019 and 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start18 Mar 2020
- Primary completion18 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Number of Patients During the Studying PeriodStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 11,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BELIN Delphine, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668937
- Sponsor's protocol ID
- 2020PI235
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy
- ClinicalTrials.gov ID
- NCT04668937
- Acronym / sponsor ID
- 2020PI235
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,000 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Dec 2020 (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.
The first period of COVID 19 Lockdown Measures (From 18 March to 11 may 2020) change the French people way of life and their medicine knowledges. A study which evaluates the Nancy's Pediatric emergencies population utilization during this time could detect pathological changes. The medical impact of Home Confinement will show an increase (trauma, maltreatment) or decrease (virus disease) of several pathology. The study aims to help clinicians to the children care if another time of Home Confinement happened. The main objective is to evaluate the behavioural changes and the reason consultation in Nancy's Pediatric Emergencies from 18 March to 30 June 2020 comparate to the same time in 2019. We will continue the search after the end of Home Confinement until 30 June 2020 to evaluate what happened just after.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children who came to the Nancy's Pediatric emergencies during the study period in 2019 | – | – |
| Children who came to the Nancy's Pediatric emergencies during the study period in 2020 | – | – |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- All children who came to the Nancy's Pediatric emergencies during the period of the 18 march to the 30 June 2019 and 2020
Key inclusion criteria (1 listed)
- children who are cared during the study period to the Nancy's pediatric emergencies
Key exclusion criteria (2 listed)
- be more than 18 years old
- Not being seen by a doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patient who came to Nancy's pediatric emergencies during the study period
Time frame: from 18 March to 30 June 2019 and 2020
Reason of consultation during the study period
Time frame: from 18 March to 30 June 2019 and 2020
2 secondary outcomes
Number of children who was send by a General practician
Time frame: from 18 March to 30 June 2019 and 2020
Medical reason to be sending by a General practician
Time frame: from 18 March to 30 June 2019 and 2020
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 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
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 Number of Patients During the Studying Period and Reason for Consultation, run by Central Hospital, Nancy, France at 1 site in France.
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 2 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 16 Dec 2020. 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 France. 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?
Number of patient who came to Nancy's pediatric emergencies during the study period (time frame: from 18 March to 30 June 2019 and 2020). The study lists 2 primary outcomes in all. 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 16 Dec 2020.