NCT06797921

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Dec 2024Dec 2029

First Submitted

Initial submission to the registry

December 3, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

December 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 29, 2025

Status Verified

October 1, 2024

Enrollment Period

5.1 years

First QC Date

December 3, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

pediatric palliative care

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Cardiologia Pediatrica

Bologna, Bologna, 40138, Italy

NOT YET RECRUITING

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Neonatologia e Terapia Intensiva Neonatale

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Oncoematologia Pediatrica

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Rianimazione Pediatrica

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS Istituto delle Scienze Neurologiche di Bologna, U.O.C. Neuropsichiatria dell'età pediatria

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

  • Daniele Zama, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Zama, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

January 29, 2025

Study Start

December 3, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

January 29, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations