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NCT Number: NCT06291649

Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age

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).

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Key information

Conditions

Acute Intoxication

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Santa Maria Annunziata, Bagno a Ripoli, Firenze, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determination of Incidence of intoxication in paediatric children

    Time frame: 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.

  2. Determination of Prevalence of intoxication in paediatric children

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco De Luca

CONTACT

[email protected]

0555662051

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Mar 4, 2024
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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