Impact of Spa Treatments on the Consumption of Care in Children

Completed

• Conditions: Respiratory Disease; Dermatologic Disease; Otorhinolaryngologic Diseases
• Interventions: Drug: Drug consumption

• Registration Number: NCT03931226
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-30
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8372

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
National cohort	Drug consumption	National level through the use of the "EGB" database (General Sample of Beneficiaries)
Departmental cohort	Drug consumption	Department level of the Haute-Garonne through the use of the 'POMME' cohort (PrescriptiOns Medicines Mother Children)

Primary Outcome Measures

Name	Time	Method
Drug consumption	until 7 years-old of children	number of Daily Defined Doses (DDDs)

Secondary Outcome Measures

Name	Time	Method
impact of SPA treatment on the pathology	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
Medical costs	until 7 years-old of children	impact of spa treatments on the consumption of medicines and care in terms of cost to society.
Description of spa treatment	until 7 years-old of children	Number and type of spa treatment
Population of children	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
Compare 2 data sources	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

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France