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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Impact of Spa Treatments on the Consumption of Care in Children

Clinicaltrials.gov identifier NCT03931226

Recruitment Status Active, not recruiting

First Posted April 30, 2019

Last update posted July 30, 2020

Study Description

Brief 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. 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.

  • Condition or Disease:Respiratory Disease
    Otorhinolaryngologic Diseases
    Dermatologic Disease
  • Intervention/Treatment: Drug: Drug consumption
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 8372 participants
  • Observational Model: Case-Control
  • Time Perspective: Retrospective
  • Official Title: Impact of Spa Treatments on the Consumption of Care in Children
  • Actual Study Start Date: June 2018
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: December 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Departmental cohort
Department level of the Haute-Garonne through the use of the 'POMME' cohort (PrescriptiOns Medicines Mother Children)
Drug: Drug consumption
number of Daily Defined Doses (DDDs) of medications prescribed and given to children in connection with the indication of the spa treatment
: National cohort
National level through the use of the "EGB" database (General Sample of Beneficiaries)
Drug: Drug consumption
number of Daily Defined Doses (DDDs) of medications prescribed and given to children in connection with the indication of the spa treatment
Outcome Measures
  • Primary Outcome Measures: 1. Drug consumption [ Time Frame: until 7 years-old of children ]
    number of Daily Defined Doses (DDDs)
  • Secondary Outcome Measures: 1. Description of spa treatment [ Time Frame: until 7 years-old of children ]
    Number and type of spa treatment
  • 2. Population of children [ Time Frame: until 7 years-old 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
  • 3. Compare 2 data sources [ Time Frame: until 7 years-old of children ]
    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
  • 4. impact of SPA treatment on the pathology [ Time Frame: until 7 years-old of children ]
    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
  • 5. Medical costs [ Time Frame: until 7 years-old of children ]
    impact of spa treatments on the consumption of medicines and care in terms of cost to society.
Eligibility Criteria
  • Ages Eligible for Study: 1 to 15 Year (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • 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).
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

Contacts and Locations
Contacts
Locations

France
University Hospital Toulouse
Toulouse

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Agnès Sommet, MD PhD University Hospital, Toulouse

More Information
  • Responsible Party: University Hospital, Toulouse
  • ClinicalTrials.gov Identifier: NCT03931226 History of Changes
  • Other Study ID Numbers: RC31/18/0420
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: July 30, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Toulouse: drug consumption
  • Additional relevant MeSH terms: Respiration Disorders
    Respiratory Tract Diseases
    Otorhinolaryngologic Diseases
    Skin Diseases