Effects of Italian Law 219/2017 in Pedi… | Clinical Trial

Key information

Conditions

Refusal of Treatment Behavior Health Behavior Treatment Adherence and Compliance Treatment Refusal

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Sant'Orsola Malpighi, Bologna, Italy

About this study

In Italy in January 2018, Law 219/2017 came into effect after years of discussion regarding the possibility of refusing potentially life-saving health treatments, with its general principles being respect of life, human dignity, and personal self-determination, and introducing the concept of Advance Care Planning, the possibility for the patient to refuse medical treatment stating also that the patient cannot demand health treatments contrary to the law, professional ethics or good clinical-care practices letting the physician protected by the law in not providing interventions that he/she judges contrary to the patient's best health interest.

This study aims to investigate pediatric intensive care providers' knowledge, perceptions, and experiences with Law 219/2017 by means of a national multicentric non-interventional cross-sectional study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Healthcare personnel employed in a pediatric intensive care units

Exclusion criteria

None

Treatment and study plan

Questionnaire Administration

Other

Participants are required to complete a survey collecting anonymous data

Primary outcomes

Knowledge of the Italian Law 219/2017

Time frame: Through study completion, an average of three months

The level of knowledge of the Italian law 219/2017, will be assessed through a survey developed drafting questions and answers by a multiprofessional panel of international experts in PICU, Bioethics, and research methodology. This survey contains questions on the law and also personal reflections on the choices made by healthcare professionals in the case studies included.

The questions will not be given a score, the data analysis will be purely qualitative.
Experience about the application of the Italian Law 219/2017

Time frame: Through study completion, an average of three months

The questions, which were constructed by a multidisciplinary team, contain a section to explore the personal experience of the respondents during their shifts in intensive care.

Study contacts

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

Matteo Martinato, PhD

CONTACT

[email protected]

+393472306806

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

University of Turin, Italy

Registry information

Official study title

A National Survey on the Perceived Effects of Italian Law 219/2017 in Pediatric Intensive Care Units

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 30, 2025
Registry last updated: Nov 28, 2025

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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