Analysis of the Hospital Node in the Management of Acute Events of Patients Referred to Pediatric Palliative Care (NO_SCUSE)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Palliative Care

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 Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Daniele Zama, MD; Phone Number: 0512144622; Email: daniele.zama2@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva
    • Contact: Daniele Zama, MD
    • Contact: Daniele Zama, MD; Phone Number: 0512144622; Email: daniele.zama2@unibo.it
  • Bologna, Italy, 40138
    • Not yet recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Cardiologia Pediatrica
    • Contact: Simone Bonetti, MD; Phone Number: 0512143650; Email: simone.bonetti@aosp.bo.it
    • Contact: Simone Bonetti, MD
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Neonatologia e Terapia Intensiva Neonatale
    • Contact: Chiara Locatelli, MD; Phone Number: 0512144463; Email: chiara.locatelli@aosp.bo.it
    • Contact: Chiara Locatelli, MD
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Oncoematologia Pediatrica
    • Contact: Tamara Belotti, MD; Phone Number: 0512144639; Email: tamara.belotti@aosp.bo.it
    • Contact: Tamara Belotti, MD
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria
    • Contact: Emanuela Di Palmo, MD; Phone Number: 0512144653; Email: emanuela.dipalmo@aosp.bo.it
    • Contact: Emanuela Di Palmo, MD
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Rianimazione Pediatrica
    • Contact: Maria Cristina Mondardini, MD; Phone Number: 0512143650; Email: mariacristina.mondardini@aosp.bo.it
    • Contact: Maria Cristina Mondardini, MD
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Istituto delle Scienze Neurologiche di Bologna, U.O.C. Neuropsichiatria dell'età pediatria
    • Contact: Veronica Di Pisa, MD; Phone Number: 3333927372; Email: veronica.dipisa@aosp.bo.it
    • Contact: Veronica Di Pisa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with a diagnosis for CPP-candidate diseases at the OUs involved in the study

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of the number of emergency room admissions	Number of admissions to the PS	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Daniele Zama, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pediatric palliative care
• Other Study ID Numbers: NOsCUsE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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