Paediatric TraumaNCT04760886
Paediatric Rural vs Urban Trauma
An observational study of Paediatric Trauma, run by Mrs Jennifer M Dunn at 1 site in United Kingdom.
Trial summary
Retrospective cohort study examining paediatric trauma admission over 1 year in a rural hospital vs urban centre Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Paediatric Trauma
- What is being tested?
- Type of hospital (rural DGH vs Urban MTC)
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 1 Apr 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: age 0-16yr olds with paediatric trauma, treated operatively.
Who may be able to join
- All paediatric trauma in each centre over the above time frame, treated operatively, seen on an acute orthopaedic take
Who cannot join
- Adults, non-operative trauma
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Jennifer Dunn, Raigmore hospital orthopaedic department
Inverness, Scotland, IV2 3XP
About this study
Official title: Comparing Paediatric Trauma Presentations in a Rural District General Hospital and an Urban Major Trauma Centre: a Retrospective Cohort Study
Retrospective cohort study examining paediatric trauma admission over 1 year in a rural hospital vs urban centre
Read the detailed description
As above. All patient data was anonymised.
- Conditions
- Paediatric Trauma
- Being tested
- Type of hospital (rural DGH vs Urban MTC)
- Keywords
- Paediatric trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of hospital (rural DGH vs Urban MTC)Other
In this small cohort study, the hospital in which the patients were treated was the intervention. One was in a rural area and was a district general, whereas one was in an urban enviroment and was a major trauma centre.
| Study group | Role | What they receive |
|---|---|---|
| Urban trauma cohort | All paediatric trauma admissions in an urban, MTC treated operatively, isolated from a departmental trauma list between 1st April 2019- 1st April 2021 Receives: Other: Type of hospital (rural DGH vs Urban MTC) | |
| Rural trauma cohort | All paediatric trauma admissions in a rural district general, treated operatively, isolated from a departmental trauma list between 1st April 2019- 1st April 2021 Receives: Other: Type of hospital (rural DGH vs Urban MTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of operation performed
Type of orthopaedic intervention documented
Measured: 1st April 2019- 1st April 2020
Distribution of type of paediatric trauma
Sub-types of fractures seen documented
Measured: 1st April 2019- 1st April2020
Secondary outcomes (1)
Seasonality of trauma
winter vs summer months trauma numbers documented
Measured: 1st April 2019- 1st April 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Apr 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric TraumaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mrs Jennifer M Dunn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mrs Jennifer M Dunn, NHS Highland
- Investigators
- Jennifer Dunn, Principal investigator, NHS Highland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760886
- Sponsor's protocol ID
- Paediatric trauma study
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Paediatric Trauma Presentations in a Rural District General Hospital and an Urban Major Trauma Centre: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04760886
- Acronym / sponsor ID
- Paediatric trauma study
- Conditions
- Paediatric Trauma
- Keywords
- Paediatric trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mrs Jennifer M DunnUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 18 Feb 2021 (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.
Retrospective cohort study examining paediatric trauma admission over 1 year in a rural hospital vs urban centre
Detailed description
As above. All patient data was anonymised.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urban trauma cohort | – | Other: Type of hospital (rural DGH vs Urban MTC)All paediatric trauma admissions in an urban, MTC treated operatively, isolated from a departmental trauma list between 1st April 2019- 1st April 2021 |
| Rural trauma cohort | – | Other: Type of hospital (rural DGH vs Urban MTC)All paediatric trauma admissions in a rural district general, treated operatively, isolated from a departmental trauma list between 1st April 2019- 1st April 2021 |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- age 0-16yr olds with paediatric trauma, treated operatively.
Key inclusion criteria (1 listed)
- All paediatric trauma in each centre over the above time frame, treated operatively, seen on an acute orthopaedic take
Key exclusion criteria (1 listed)
- Adults, non-operative trauma
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 |
|---|---|---|
| Type of hospital (rural DGH vs Urban MTC)In this small cohort study, the hospital in which the patients were treated was the intervention. One was in a rural area and was a district general, whereas one was in an urban enviroment and was a major trauma centre. | Other | Rural trauma cohort, Urban trauma cohort |
Primary outcome
Type of operation performed
Time frame: 1st April 2019- 1st April 2020
Type of orthopaedic intervention documented
Distribution of type of paediatric trauma
Time frame: 1st April 2019- 1st April2020
Sub-types of fractures seen documented
1 secondary outcome
Seasonality of trauma
Time frame: 1st April 2019- 1st April 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 18 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Jennifer Dunn principal investigator
NHS Highland
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 Paediatric Trauma, run by Mrs Jennifer M Dunn at 1 site in United Kingdom.
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 18 Feb 2021. 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 United Kingdom. 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?
Type of operation performed (time frame: 1st April 2019- 1st April 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 18 Feb 2021.