Clinical trial NCT06291649: Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age
Official title: Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Intoxication
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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).


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

Primary outcomes:
measure: Determination of Incidence of intoxication in paediatric children
timeFrame: through study completion, an average of 1 year
measure: Determination of Prevalence of intoxication in paediatric children
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bagno A Ripoli
country: Italy
facility: Ospedale Santa Maria Annunziata
state: Firenze
city: Borgo San Lorenzo
country: Italy
facility: Ospedale Del Mugello
state: Firenze
city: Forlì
country: Italy
facility: Ospedale G B Morgagni
state: Forlì-Cesena
city: Legnago
country: Italy
facility: Mater Salutis
state: Verona
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Bolzano
country: Italy
facility: Ospedale Centrale Bolzano
city: Cagliari
country: Italy
facility: Ospedale Brotzu
city: Empoli
country: Italy
facility: Ospedale San Giuseppe
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Grosseto
country: Italy
facility: Ospedale Misericordia
city: Messina
country: Italy
facility: Policlinico Messina
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Padova
country: Italy
facility: Ao Padova
city: Parma
country: Italy
facility: Nuovo Ospedale Dei Bambini
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Pescara
country: Italy
facility: Policlinico Pescara
city: Pisa
country: Italy
facility: Ospedale Santa Chiara - Cisanello
city: Pistoia
country: Italy
facility: Ospedale San Jacopo
city: Pordenone
country: Italy
facility: Ospedale Civile Santa Maria Degli Angel
city: Prato
country: Italy
facility: Ospedale Santo Stefano
city: Rimini
country: Italy
facility: Ospedale Infermi
city: Roma
country: Italy
facility: CAV Gemelli
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Torino
country: Italy
facility: Ospedale Regina Margherita
city: Trento
country: Italy
facility: Santa Chiara
city: Treviso
country: Italy
facility: Ulss 2 Marca Trevigiana
city: Trieste
country: Italy
facility: Burlo Garofalo
city: Udine
country: Italy
facility: Clinica Pediatrica Udine
city: Verona
country: Italy
facility: CAV Veneto
city: Verona
country: Italy
facility: Ospedale Della Donna E Del Bambino
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
Study officials:
References: