Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06291649

Enrollment

Registered

2024-03-04

Start date

2023-04-05

Completion date

2033-08-05

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Intoxication

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Determination of Incidence of intoxication in paediatric children	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.
Determination of Prevalence of intoxication in paediatric children	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.

Countries

Italy

Contacts

Primary ContactMarco De Luca

marco.deluca@meyer.it0555662051

Outcome results