Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age

Acute Intoxication Clinical Trial

Official title:

Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291649
• Other study ID #: AMIETOX
• Status: Recruiting
• Start date: April 5, 2023
• Est. completion date: August 5, 2033

Study information

• Verified date: February 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Marco De Luca
• Phone: 0555662051
• Email: marco.deluca[@]meyer.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 5, 2033
• Est. primary completion date: April 5, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Intoxication

Locations

Country	Name	City	State
Italy	Ospedale Santa Maria Annunziata	Bagno A Ripoli	Firenze
Italy	Ospedale Maggiore	Bologna
Italy	Ospedale Centrale Bolzano	Bolzano
Italy	Ospedale Del Mugello	Borgo San Lorenzo	Firenze
Italy	Ospedale Brotzu	Cagliari
Italy	Ospedale San Giuseppe	Empoli
Italy	Meyer Children's Hospital IRCCS	Florence
Italy	Ospedale G B Morgagni	Forlì	Forlì-Cesena
Italy	Ospedale Misericordia	Grosseto
Italy	Mater Salutis	Legnago	Verona
Italy	Policlinico Messina	Messina
Italy	Ospedale San Francesco	Nuoro
Italy	Ao Padova	Padova
Italy	Nuovo Ospedale Dei Bambini	Parma
Italy	Policlinico San Matteo	Pavia
Italy	Policlinico Pescara	Pescara
Italy	Ospedale Santa Chiara - Cisanello	Pisa
Italy	Ospedale San Jacopo	Pistoia
Italy	Ospedale Civile Santa Maria Degli Angel	Pordenone
Italy	Ospedale Santo Stefano	Prato
Italy	Ospedale Infermi	Rimini
Italy	CAV Gemelli	Roma
Italy	Policlinico Gemelli	Roma
Italy	Ospedale Regina Margherita	Torino
Italy	Santa Chiara	Trento
Italy	Ulss 2 Marca Trevigiana	Treviso
Italy	Burlo Garofalo	Trieste
Italy	Clinica Pediatrica Udine	Udine
Italy	CAV Veneto	Verona
Italy	Ospedale Della Donna E Del Bambino	Verona
Italy	Ospedale San Bortolo	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Incidence of intoxication in paediatric children	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.	through study completion, an average of 1 year
Primary	Determination of Prevalence of intoxication in paediatric children	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.	through study completion, an average of 1 year