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Recruiting NCT06291649

Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age

Observational Acute Intoxication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Intoxication. Basic parameters: 1 months — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Primary outcome measures

  • Determination of Incidence of intoxication in paediatric children [Time frame: through study completion, an average of 1 year]
  • Determination of Prevalence of intoxication in paediatric children [Time frame: through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 31 centers
  • Ospedale Santa Maria Annunziata — Bagno a Ripoli
  • Ospedale Del Mugello — Borgo San Lorenzo
  • Ospedale G B Morgagni — Forlì
  • Mater Salutis — Legnago
  • Ospedale Maggiore — Bologna
  • Ospedale Centrale Bolzano — Bolzano
  • Ospedale Brotzu — Cagliari
  • Ospedale San Giuseppe — Empoli
  • … and 23 more centers

Identifiers

NCT: NCT06291649 · AMIETOX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗