Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age

Recruiting

• Conditions: Acute Intoxication

• Registration Number: NCT06291649
• Lead Sponsor: Meyer Children's Hospital IRCCS

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-05
• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Primary Completion: 2033-04-05
• Study Completion: 2033-08-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (31)

Ospedale Santa Maria Annunziata; 🇮🇹 Bagno A Ripoli, Firenze, Italy

Ospedale Del Mugello; 🇮🇹 Borgo San Lorenzo, Firenze, Italy

Ospedale G B Morgagni; 🇮🇹 Forlì, Forlì-Cesena, Italy

Mater Salutis; 🇮🇹 Legnago, Verona, Italy

Ospedale Maggiore; 🇮🇹 Bologna, Italy

Ospedale Centrale Bolzano; 🇮🇹 Bolzano, Italy

Ospedale Brotzu; 🇮🇹 Cagliari, Italy

Ospedale San Giuseppe; 🇮🇹 Empoli, Italy

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy

Ospedale Misericordia; 🇮🇹 Grosseto, Italy

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