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Completed

NCT Number: NCT03931226

Impact of Spa Treatments on the Consumption of Care in Children

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.

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Key information

Conditions

Respiratory Disease Dermatologic Disease Otorhinolaryngologic Diseases Respiration Disorders Respiratory Tract Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Toulouse

Toulouse, 31000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug consumption

Drug

number of Daily Defined Doses (DDDs) of medications prescribed and given to children in connection with the indication of the spa treatment

Primary outcomes

  1. Drug consumption

    Time frame: until 7 years-old of children

    number of Daily Defined Doses (DDDs)

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: PEDIATHERM

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2019
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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