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Clinical Trials/NCT06291649
NCT06291649
Recruiting
Not Applicable

Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age

Meyer Children's Hospital IRCCS31 sites in 1 country90 target enrollmentApril 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Intoxication
Sponsor
Meyer Children's Hospital IRCCS
Enrollment
90
Locations
31
Primary Endpoint
Determination of Prevalence of intoxication in paediatric children
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings.

The primary objective of the study is to assess the epidemiology of acute intoxications in paediatric age with respect to the social and care factors associated with it in order to then implement in the future a better diagnostic-therapeutic management modality on a national level.

Thi is a prospective non-profit multicentre observational cohort study on acute intoxications in the paediatric age, conducted by AMIETOX, aimed at CAVs (Poison Control Centres) and PSPs (Paediatric emergency room).

Registry
clinicaltrials.gov
Start Date
April 5, 2023
End Date
August 5, 2033
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Meyer Children's Hospital IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Marco De Luca

Principal Investigator

Meyer Children's Hospital IRCCS

Eligibility Criteria

Inclusion Criteria

  • Subjects between the ages of 1 month and 16 years who report to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication (defined as contact with a substance that is toxic per se or in such quantities as to cause a harmful effect on the body or administered by a route not intended for that substance)

Exclusion Criteria

  • not acquired informed consent

Outcomes

Primary Outcomes

Determination of Prevalence of intoxication in paediatric children

Time Frame: through study completion, an average of 1 year

Subjects will be stratified by age and type of assumed toxic substance. The prevalence of intoxication in this population will be measured calculating the number of people in the sample with the characteristic of interest, divided by the total number of people in the sample.

Determination of Incidence of intoxication in paediatric children

Time Frame: through study completion, an average of 1 year

Subjects will be stratified by age and type of assumed toxic substance. The incidence of intoxication in paediatric children will be measured taking the total number of new cases of intoxication and divided that by the sum of the person-time of the at-risk population.

Study Sites (31)

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