Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age
1 other identifier
observational
90
1 country
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2023
CompletedFirst Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 5, 2033
March 4, 2024
February 1, 2024
10 years
February 15, 2024
February 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Eligibility Criteria
subject between 1 month and 16 years that has reportet to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication
You may qualify if:
- 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)
You may not qualify if:
- not acquired informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze, 50139, Italy
Ospedale Del Mugello
Borgo San Lorenzo, Firenze, 50139, 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, 50053, Italy
Meyer Children's Hospital IRCCS
Florence, 50139, Italy
Ospedale Misericordia
Grosseto, 58100, Italy
Policlinico Messina
Messina, Italy
Ospedale San Francesco
Nuoro, Italy
Ao Padova
Padua, 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, 51100, Italy
Ospedale Civile Santa Maria Degli Angel
Pordenone, Italy
Ospedale Santo Stefano
Prato, 59100, 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, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 15, 2024
First Posted
March 4, 2024
Study Start
April 5, 2023
Primary Completion (Estimated)
April 5, 2033
Study Completion (Estimated)
August 5, 2033
Last Updated
March 4, 2024
Record last verified: 2024-02