Effects of Italian Law 219/2017 in Pediatric Intensive Care Units

November 23, 2025 updated by: University of Padova

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Healthcare personnel employed in a pediatric intensive care units

Description

Inclusion Criteria:

  • Healthcare personnel employed in a pediatric intensive care units

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthcare personnel
Healthcare personnel employed in pediatric intensive care units
Other: Questionnaire administration
Participants are required to complete a survey collecting anonymous data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of three months
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.
Through study completion, an average of three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Collaborators

University of Turin, Italy

Investigators

  • Principal Investigator: Matteo Martinato, PhD, University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 25, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

July 3, 2025

First Submitted That Met QC Criteria

July 21, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PES-219-PICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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