Respiratory DiseasePEDIATHERMNCT03931226
Impact of Spa Treatments on the Consumption of Care in Children
An observational study of Respiratory Disease and Otorhinolaryngologic Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Children represent 1.2% of the spa population in France. Spa treatments, including climatic stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology and dermatological conditions. Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease, Otorhinolaryngologic Diseases, Dermatologic Disease
- What is being tested?
- Drug consumption
- How many people
- 8,372 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 31 Dec 2022
- 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 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This pharmacoepidemiology study of the "observational study" type, in real life, will concern children aged 1 to 15 living in France at the time of the study. It will be conducted at the departmental level of the Haute-Garonne through the use of the APPLE database (PrescriptiOns Medicines Mother Children) and at the national level through the use of the database. EGB (General Sample of Beneficiaries).
Who may be able to join
- Children living in France at the time of the study
- 'POMME' cohort : children included at birth and 'EGB' cohort : children from birth to 15 years-old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Children represent 1.2% of the spa population in France. Spa treatments, including climatic stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology and dermatological conditions. The benefits after spa treatments are the improvement of the symptoms of the pathology, the quality of life and in particular the reduction of drug exposures.
Few authors have recently investigated the impact of spa treatments on the health of children and society, while care has changed significantly in recent years. Moreover, no real-life study of a large sample of children seems to have been conducted in this area. The present study plan to conduct a pharmacoepidemiology study on medico-administrative databases of the "observational study" type, in real life.
- Being tested
- Drug consumption
- Keywords
- drug consumption
- Medical subject headings
- Respiration Disorders, Otorhinolaryngologic Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug consumptionDrug
number of Daily Defined Doses (DDDs) of medications prescribed and given to children in connection with the indication of the spa treatment
| Study group | Role | What they receive |
|---|---|---|
| Departmental cohort | Department level of the Haute-Garonne through the use of the 'POMME' cohort (PrescriptiOns Medicines Mother Children) Receives: Drug: Drug consumption | |
| National cohort | National level through the use of the "EGB" database (General Sample of Beneficiaries) Receives: Drug: Drug consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug consumption
number of Daily Defined Doses (DDDs)
Measured: until 7 years-old of children
Secondary outcomes (5)
Description of spa treatment
Number and type of spa treatment
Measured: until 7 years-old of children
Population of children
population of children in terms of age, weight and weight characteristics and health through compulsory health certificates at 8 days, 9 months and 2 years, but also use of care and medication
Measured: until 7 years-old of children
Compare 2 data sources
Compare the population of children from the 2 data sources used for this project (departmental level with the cohort 'POMME' and national level with the 'EGB') to determine if the geographical situation of the department of Haute-Garonne influences the management of this type of diseases
Measured: until 7 years-old of children
impact of SPA treatment on the pathology
Study the impact of spa treatments on the consumption of care in connection with the pathology that motivated the spa treatment, before and after the SPA
Measured: until 7 years-old of children
Medical costs
impact of spa treatments on the consumption of medicines and care in terms of cost to society.
Measured: until 7 years-old of children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Jun 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 8,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès Sommet, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931226
- Sponsor's protocol ID
- RC31/18/0420
- Acronym
- PEDIATHERM
- Status last verified
- Nov 2023
- First submitted
- 25 Apr 2019
- Last updated
- 13 Nov 2023
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Spa Treatments on the Consumption of Care in Children
- ClinicalTrials.gov ID
- NCT03931226
- Acronym / sponsor ID
- PEDIATHERM / RC31/18/0420
- Keywords
- drug consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,372 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Apr 2019 (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.
Children represent 1.2% of the spa population in France. Spa treatments, including climatic stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology and dermatological conditions. The benefits after spa treatments are the improvement of the symptoms of the pathology, the quality of life and in particular the reduction of drug exposures.
Few authors have recently investigated the impact of spa treatments on the health of children and society, while care has changed significantly in recent years. Moreover, no real-life study of a large sample of children seems to have been conducted in this area. The present study plan to conduct a pharmacoepidemiology study on medico-administrative databases of the "observational study" type, in real life.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Departmental cohort | – | Drug: Drug consumptionDepartment level of the Haute-Garonne through the use of the 'POMME' cohort (PrescriptiOns Medicines Mother Children) |
| National cohort | – | Drug: Drug consumptionNational level through the use of the "EGB" database (General Sample of Beneficiaries) |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This pharmacoepidemiology study of the "observational study" type, in real life, will concern children aged 1 to 15 living in France at the time of the study. It will be conducted at the departmental level of the Haute-Garonne through the use of the APPLE database (PrescriptiOns Medicines Mother Children) and at the national level through the use of the database. EGB (General Sample of Beneficiaries).
Key inclusion criteria (2 listed)
- Children living in France at the time of the study
- 'POMME' cohort : children included at birth and 'EGB' cohort : children from birth to 15 years-old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Drug consumptionnumber of Daily Defined Doses (DDDs) of medications prescribed and given to children in connection with the indication of the spa treatment | Drug | Departmental cohort, National cohort |
Primary outcome
Drug consumption
Time frame: until 7 years-old of children
number of Daily Defined Doses (DDDs)
5 secondary outcomes
Description of spa treatment
Time frame: until 7 years-old of children
Population of children
Time frame: until 7 years-old of children
Compare 2 data sources
Time frame: until 7 years-old of children
impact of SPA treatment on the pathology
Time frame: until 7 years-old of children
Medical costs
Time frame: until 7 years-old of children
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 13 Nov 2023.
- 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.
Agnès Sommet, MD PhD principal investigator
University Hospital, Toulouse
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 Respiratory Disease and Otorhinolaryngologic Diseases, run by University Hospital, Toulouse 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 2 inclusion and 0 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 13 Nov 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 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?
Drug consumption (time frame: until 7 years-old of children). 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 13 Nov 2023.