Impact of Spa Treatments on the Consumption of Care in Children

Respiratory Disease Clinical Trial

— PEDIATHERM  

Official title:

Impact of Spa Treatments on the Consumption of Care in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931226
• Other study ID #: RC31/18/0420
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8372
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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:

Related Conditions & MeSH terms

• Dermatologic Disease
• Otorhinolaryngologic Diseases
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Skin Diseases

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug consumption	number of Daily Defined Doses (DDDs)	until 7 years-old of children
Secondary	Description of spa treatment	Number and type of spa treatment	until 7 years-old of children
Secondary	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
Secondary	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
Secondary	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
Secondary	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