Pediatric Palliative CareNO_SCUSENCT06797921
Analysis of the Hospital Node in the Management of Acute Events of Patients Referred to Pediatric Palliative Care
An observational study of Pediatric Palliative Care, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 7 sites in Italy.
Trial summary
This study aims to analyze the role of the hospital node in the acute event management of pediatric patients referred to Pediatric Palliative Care. Patients eligible for pediatric palliative care experience frequent hospitalizations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Palliative Care
- How many people
- 350 participants
- Where
- 7 sitesItaly
- Study dates
- 3 Dec 2024to 31 Dec 2029
- 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: Patients admitted with a diagnosis for CPP-candidate diseases at the OUs involved in the study
Who may be able to join
- Living patients aged <18 years at the time of the event
- Patients with conditions eligible for PPCs according to Association for Children's Palliative Care/Royal College of Pediatrics and Child Health
Who cannot join
- NA
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Not yet recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Cardiologia Pediatrica
Bologna, Bologna, 40138
Simone Bonetti, MD, 0512143650, simone.bonetti@aosp.bo.it
Simone Bonetti, MD
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Neonatologia e Terapia Intensiva Neonatale
Bologna, Bologna, 40138
Chiara Locatelli, MD, 0512144463, chiara.locatelli@aosp.bo.it
Chiara Locatelli, MD
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Oncoematologia Pediatrica
Bologna, Bologna, 40138
Tamara Belotti, MD, 0512144639, tamara.belotti@aosp.bo.it
Tamara Belotti, MD
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva
Bologna, Bologna, 40138
Daniele Zama, MD, 0512144622, daniele.zama2@unibo.it
Daniele Zama, MD
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria
Bologna, Bologna, 40138
Emanuela Di Palmo, MD, 0512144653, emanuela.dipalmo@aosp.bo.it
Emanuela Di Palmo, MD
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Rianimazione Pediatrica
Bologna, Bologna, 40138
Maria Cristina Mondardini, MD, 0512143650, mariacristina.mondardini@aosp.bo.it
Maria Cristina Mondardini, MD
- Recruiting
IRCCS Istituto delle Scienze Neurologiche di Bologna, U.O.C. Neuropsichiatria dell'età pediatria
Bologna, Bologna, 40138
Veronica Di Pisa, MD, 3333927372, veronica.dipisa@aosp.bo.it
Veronica Di Pisa, MD
About this study
This study aims to analyze the role of the hospital node in the acute event management of pediatric patients referred to Pediatric Palliative Care. Patients eligible for pediatric palliative care experience frequent hospitalizations. In oncology patients, hospitalizations are mainly for the treatment of the disease and the performance of diagnostic and/or therapeutic procedures, whereas in the case of non-oncology children, admissions occur particularly for the occurrence of complications, which may affect different organs and systems. Hospitalization times are on average longer, so much so that in some cases they can even exceed 100 consecutive days, and have a high risk of re-hospitalization.
Read the detailed description
In Italy, the prevalence of children needing CPP is estimated at 34-54 per 100,000 population, for a total number between 20,000 and 35,000 children. Prevalence data and projections performed on the British population show that children with life-limiting conditions are progressively increasing. The reason for this increase can be attributed to medical and technological advances that have enabled reductions in neonatal and pediatric mortality and increased the survival of pediatric patients with severe and life-threatening disease. Caring for these patients is complex as they require specific medical and management knowledge and coordination within the health care system. The care of children with medical complexity is interdisciplinary, with different professionals playing a central role for these children. Teamwork is necessary not only for responding to clinical problems but also for defining goals of care and for communication to the patient and family.
- Conditions
- Pediatric Palliative Care
- Keywords
- pediatric palliative care
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the number of emergency room admissions
Number of admissions to the PS
Measured: through study completion, an average of 1 year
hospital admissions of the pediatric population eligible for Pediatric Palliative Care at the OUs involved in the study.
number and duration of hospitalization episodes by year, with prevalence calculation.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start3 Dec 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Palliative CareStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Zama, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797921
- Sponsor's protocol ID
- NOsCUsE
- Acronym
- NO_SCUSE
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Hospital Node in the Management of Acute Events of Patients Referred to Pediatric Palliative Care
- ClinicalTrials.gov ID
- NCT06797921
- Acronym / sponsor ID
- NO_SCUSE / NOsCUsE
- Conditions
- Pediatric Palliative Care
- Keywords
- pediatric palliative care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Jan 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 analyze the role of the hospital node in the acute event management of pediatric patients referred to Pediatric Palliative Care. Patients eligible for pediatric palliative care experience frequent hospitalizations. In oncology patients, hospitalizations are mainly for the treatment of the disease and the performance of diagnostic and/or therapeutic procedures, whereas in the case of non-oncology children, admissions occur particularly for the occurrence of complications, which may affect different organs and systems. Hospitalization times are on average longer, so much so that in some cases they can even exceed 100 consecutive days, and have a high risk of re-hospitalization.
Detailed description
In Italy, the prevalence of children needing CPP is estimated at 34-54 per 100,000 population, for a total number between 20,000 and 35,000 children. Prevalence data and projections performed on the British population show that children with life-limiting conditions are progressively increasing. The reason for this increase can be attributed to medical and technological advances that have enabled reductions in neonatal and pediatric mortality and increased the survival of pediatric patients with severe and life-threatening disease. Caring for these patients is complex as they require specific medical and management knowledge and coordination within the health care system. The care of children with medical complexity is interdisciplinary, with different professionals playing a central role for these children. Teamwork is necessary not only for responding to clinical problems but also for defining goals of care and for communication to the patient and family.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted with a diagnosis for CPP-candidate diseases at the OUs involved in the study
Key inclusion criteria (2 listed)
- Living patients aged <18 years at the time of the event
- Patients with conditions eligible for PPCs according to Association for Children's Palliative Care/Royal College of Pediatrics and Child Health
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantification of the number of emergency room admissions
Time frame: through study completion, an average of 1 year
Number of admissions to the PS
hospital admissions of the pediatric population eligible for Pediatric Palliative Care at the OUs involved in the study.
Time frame: through study completion, an average of 1 year
number and duration of hospitalization episodes by year, with prevalence calculation.
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 29 Jan 2025.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Complexity in Health, Education, and Social Support for Children and Young People With Life-limiting Conditions.
Complex Care, Medical Complexity
RecruitingEarly Phase 1
Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials
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Video Inspired Discussions About Ethical Outcomes in Pediatrics
Pediatric Cancer
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.
Daniele Zama, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Palliative Care, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 7 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 2 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Daniele Zama, MD (0512144622, daniele.zama2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of the number of emergency room admissions (time frame: through study completion, an average of 1 year). 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 29 Jan 2025.