Refusal of TreatmentNCT07093047
Effects of Italian Law 219/2017 in Pediatric Intensive Care Units
An observational study of Refusal of Treatment, run by University of Padova at 3 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refusal of Treatment
- What is being tested?
- Questionnaire administration
- How many people
- 172 participants
- Where
- 3 sitesItaly
- Study dates
- 25 Nov 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Healthcare personnel employed in a pediatric intensive care units
Who may be able to join
- Healthcare personnel employed in a pediatric intensive care units
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites
Ospedale Sant'Orsola Malpighi
Bologna
Maria Cristina Mondardini, MD, +39 3485100585, mariacristina.mondardini@aosp.bo.it
Ospedale Gaslini
Genova
Andrea Wolfler, MD, +39 3496771800, andreawolfler@gaslini.org
Università di Torino
Torino
Rosanna Irene Comoretto, RN, PhD, +39 3396670442, rosannairenecomoretto@unito.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Refusal of Treatment
- Being tested
- Questionnaire administration
- Medical subject headings
- Treatment Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationOther
Participants are required to complete a survey collecting anonymous data
| Study group | Role | What they receive |
|---|---|---|
| Healthcare personnel | Healthcare personnel employed in pediatric intensive care units Receives: Other: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of the Italian Law 219/2017
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.
Measured: Through study completion, an average of three months
Experience about the application of the Italian Law 219/2017
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.
Measured: Through study completion, an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start25 Nov 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refusal of TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turin, Italy
- Responsible party
- Sponsor
- Investigators
- Matteo Martinato, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093047
- Sponsor's protocol ID
- PES-219-PICU
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Survey on the Perceived Effects of Italian Law 219/2017 in Pediatric Intensive Care Units
- ClinicalTrials.gov ID
- NCT07093047
- Acronym / sponsor ID
- PES-219-PICU
- Conditions
- Refusal of Treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- University of Turin, Italy
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare personnel | – | Other: Questionnaire administrationHealthcare personnel employed in pediatric intensive care units |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthcare personnel employed in a pediatric intensive care units
Key inclusion criteria (1 listed)
- Healthcare personnel employed in a pediatric intensive care units
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire administrationParticipants are required to complete a survey collecting anonymous data | Other | Healthcare personnel |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matteo Martinato, PhD principal investigator
University of Padova
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refusal of Treatment, run by University of Padova at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Martinato, PhD (+393472306806, matteo.martinato@ubep.unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of the Italian Law 219/2017 (time frame: Through study completion, an average of three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.