Impact of Spa Treatments on the Consumption of Care in Children (PEDIATHERM)

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 Overview

• Status: Completed
• Conditions: Otorhinolaryngologic Diseases; Respiratory Disease; Dermatologic Disease
• Intervention / Treatment: Drug: Drug consumption

• Study Type: Observational
• Enrollment (Actual): 8372

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• 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).

Description

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:

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug consumption	number of Daily Defined Doses (DDDs)	until 7 years-old of children

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of spa treatment	Number and type of spa treatment	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	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	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	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.	until 7 years-old of children

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Agnès Sommet, MD PhD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: drug consumption
• Additional Relevant MeSH Terms: Skin Diseases; Respiration Disorders; Respiratory Tract Diseases; Otorhinolaryngologic Diseases
• Other Study ID Numbers: RC31/18/0420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No