EncephalopathyStartSPPNCT06273267
Initiating Pediatric Palliative Care in ACT Group 4
An observational study of Encephalopathy and Cerebral Palsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models. This classification includes four groups. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Encephalopathy, Cerebral Palsy, Cerebral Malformation
- What is being tested?
- Collection of data from the patient's medical file
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2023to 22 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: AP-HP (Assistance Publique - Hôpitaux de Paris) patients followed by the pediatric palliative care teams of the greater metropolitan area of Paris "Ile de France" (Robert-Debré hospital, Necker hospital or Paliped-Île-de-France Regional Pediatric Palliative Care Resource Team) between January 2020 and December 2022 and suffering from a serious non-progressive neurological disease. Robert Debré et Necker Hospitals are tertiary care hospitals. Paliped is a community based service for PPC.
Who may be able to join
- Patients aged 0 to 25
- Follow-ups at APHP
- Supported by a palliative care team from Ile de France (Robert-Debré hospital, Necker hospital or Paliped-Île-de-France Regional Pediatric Palliative Care Resource Team) between January 2020 and December 2022
- Suffering from a serious non-progressive neurological disease (ACT-4)
- Information and absence of opposition from the holders of parental authority of the minor patient and the guardian or curator of the adult patient if he is under guardianship/curatorship;
Who cannot join
- Other ACT category (1, 2, 3 or 5) of the classification of diseases by the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) during treatment
- Patients for whom there was no pediatric palliative care intervention
- Patients in palliative care without follow-up at the APHP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Pediatric Palliative Care Provision in Patients Under 25 Years of Age Classified in ACT Group 4 Within Ile de France (Metropolitan Area of Paris)
Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.
This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).
Read more
Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.
The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention.
Read the detailed description
The ACT 4 group is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).
Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.
The question of when to initiate palliative care with curative pediatric care frequently arises for specialists in pediatrics and palliative medicine. In the ACT-4 group, where the pathologies are by definition non-progressive, the initial timing and mode of intervention of palliative care are less clear. The main reasons encountered in clinical practice are: symptomatic and therapeutic assessment, goals of care discussion, and implementing a care plan. Two main modes of intervention have been identified for hospital based teams (consultations and multidisciplinary meetings) and will be confirmed by extending the study to community care. The reasons and methods of intervention will be explored in our study.
The specific history of ACT-4 patients suggests that these patients may present pediatric palliative care needs early on, but effective intervention varies greatly from one patient to another. This study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention.
- Being tested
- Collection of data from the patient's medical file
- Keywords
- Serious incurable non-progressive neurological disease, Pediatric palliative care
- Medical subject headings
- Brain Diseases, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data from the patient's medical fileOther
Collection of data from the patient's medical file. The data collected concerns the first year of follow-up (from the initial PPC intervention to one year to date post-intervention).
| Study group | Role | What they receive |
|---|---|---|
| Patients | AP-HP patients followed by the pediatric palliative care teams of Ile de France (metropolitan area of Paris) between January 2020 and December 2022 and suffering from a serious non-progressive neurological disease. Receives: Other: Collection of data from the patient's medical file |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of first pediatric palliative care intervention
The first pediatric palliative care team intervention will be listed for each patient (symptom management, multidisciplinary ethical meeting, care coordination, or team and family support). Collection of data from the patient's medical file. The data collected concerns the initial intervention.
Measured: 12 months
Secondary outcomes (2)
Description of the patient situation
Clinical description of the patient: ICD (international classification of diseases) diagnosis, acute symptoms, treatment, demographic characteristics and the place of care (hospital, hospice, palliative care unit, home).
Collection of data from the patient's medical file. The data collected concerns the first year of follow-up, from the initial pediatric palliative care intervention to one year to date post-intervention.
Measured: 12 months
Timing of pediatric palliative care intervention
Determine whether there is a significant difference in the reasons and modes of initiating pediatric palliative care depending on the precocity of the first intervention in relation to diagnosis and death if it has occurred. Analysis of time elapsed between diagnosis and palliative care intervention as well as time elapsed between palliative care and death if it has occured.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start22 Dec 2023
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EncephalopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Ashley RIDLEY, M.D., Principal investigator, Assistance Publique - Hôpitaux de ParisHélène GEFFROY, Resident, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273267
- Sponsor's protocol ID
- APHP231232
- Acronym
- StartSPP
- Status last verified
- Sep 2025
- First submitted
- 31 Jan 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Namisango E, Bristowe K, Allsop MJ, Murtagh FEM, Abas M, Higginson IJ, Downing J, Harding R. Symptoms and Concerns Among Children and Young People with Life-Limiting and Life-Threatening Conditions: A Systematic Review Highlighting Meaningful Health Outcomes. Patient. 2019 Feb;12(1):15-55. doi: 10.1007/s40271-018-0333-5.
PubMed 30361884Bender HU, Riester MB, Borasio GD, Fuhrer M. "Let's Bring Her Home First." Patient Characteristics and Place of Death in Specialized Pediatric Palliative Home Care. J Pain Symptom Manage. 2017 Aug;54(2):159-166. doi: 10.1016/j.jpainsymman.2017.04.006. Epub 2017 Jun 8.
PubMed 28602938DeCourcey DD, Silverman M, Oladunjoye A, Balkin EM, Wolfe J. Patterns of Care at the End of Life for Children and Young Adults with Life-Threatening Complex Chronic Conditions. J Pediatr. 2018 Feb;193:196-203.e2. doi: 10.1016/j.jpeds.2017.09.078. Epub 2017 Nov 22.
PubMed 29174080Good PD, Cavenagh J, Ravenscroft PJ. Survival after enrollment in an Australian palliative care program. J Pain Symptom Manage. 2004 Apr;27(4):310-5. doi: 10.1016/j.jpainsymman.2003.12.011.
PubMed 15050658Feudtner C, Kang TI, Hexem KR, Friedrichsdorf SJ, Osenga K, Siden H, Friebert SE, Hays RM, Dussel V, Wolfe J. Pediatric palliative care patients: a prospective multicenter cohort study. Pediatrics. 2011 Jun;127(6):1094-101. doi: 10.1542/peds.2010-3225. Epub 2011 May 9.
PubMed 21555495Siden H, Chavoshi N, Harvey B, Parker A, Miller T. Characteristics of a pediatric hospice palliative care program over 15 years. Pediatrics. 2014 Sep;134(3):e765-72. doi: 10.1542/peds.2014-0381.
PubMed 25157003Mack JW, Wolfe J. Early integration of pediatric palliative care: for some children, palliative care starts at diagnosis. Curr Opin Pediatr. 2006 Feb;18(1):10-4. doi: 10.1097/01.mop.0000193266.86129.47.
PubMed 16470155Himmelmann K, Sundh V. Survival with cerebral palsy over five decades in western Sweden. Dev Med Child Neurol. 2015 Aug;57(8):762-7. doi: 10.1111/dmcn.12718. Epub 2015 Feb 19.
PubMed 25694102
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Pediatric Palliative Care Provision in Patients Under 25 Years of Age Classified in ACT Group 4 Within Ile de France (Metropolitan Area of Paris)
- ClinicalTrials.gov ID
- NCT06273267
- Acronym / sponsor ID
- StartSPP / APHP231232
- Keywords
- Serious incurable non-progressive neurological disease, Pediatric palliative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 22 Feb 2024 (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.
Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.
This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).
Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.
The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention.
Detailed description
The ACT 4 group is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).
Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.
The question of when to initiate palliative care with curative pediatric care frequently arises for specialists in pediatrics and palliative medicine. In the ACT-4 group, where the pathologies are by definition non-progressive, the initial timing and mode of intervention of palliative care are less clear. The main reasons encountered in clinical practice are: symptomatic and therapeutic assessment, goals of care discussion, and implementing a care plan. Two main modes of intervention have been identified for hospital based teams (consultations and multidisciplinary meetings) and will be confirmed by extending the study to community care. The reasons and methods of intervention will be explored in our study.
The specific history of ACT-4 patients suggests that these patients may present pediatric palliative care needs early on, but effective intervention varies greatly from one patient to another. This study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Collection of data from the patient's medical fileAP-HP patients followed by the pediatric palliative care teams of Ile de France (metropolitan area of Paris) between January 2020 and December 2022 and suffering from a serious non-progressive neurological disease. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- AP-HP (Assistance Publique - Hôpitaux de Paris) patients followed by the pediatric palliative care teams of the greater metropolitan area of Paris "Ile de France" (Robert-Debré hospital, Necker hospital or Paliped-Île-de-France Regional Pediatric Palliative Care Resource Team) between January 2020 and December 2022 and suffering from a serious non-progressive neurological disease. Robert Debré et Necker Hospitals are tertiary care hospitals. Paliped is a community based service for PPC.
Key inclusion criteria (5 listed)
- Patients aged 0 to 25
- Follow-ups at APHP
- Supported by a palliative care team from Ile de France (Robert-Debré hospital, Necker hospital or Paliped-Île-de-France Regional Pediatric Palliative Care Resource Team) between January 2020 and December 2022
- Suffering from a serious non-progressive neurological disease (ACT-4)
- Information and absence of opposition from the holders of parental authority of the minor patient and the guardian or curator of the adult patient if he is under guardianship/curatorship;
Key exclusion criteria (3 listed)
- Other ACT category (1, 2, 3 or 5) of the classification of diseases by the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) during treatment
- Patients for whom there was no pediatric palliative care intervention
- Patients in palliative care without follow-up at the APHP
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 |
|---|---|---|
| Collection of data from the patient's medical fileCollection of data from the patient's medical file. The data collected concerns the first year of follow-up (from the initial PPC intervention to one year to date post-intervention). | Other | Patients |
Primary outcome
Description of first pediatric palliative care intervention
Time frame: 12 months
The first pediatric palliative care team intervention will be listed for each patient (symptom management, multidisciplinary ethical meeting, care coordination, or team and family support). Collection of data from the patient's medical file. The data collected concerns the initial intervention.
2 secondary outcomes
Description of the patient situation
Time frame: 12 months
Timing of pediatric palliative care intervention
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 30361884Namisango E, Bristowe K, Allsop MJ, Murtagh FEM, Abas M, Higginson IJ, Downing J, Harding R. Symptoms and Concerns Among Children and Young People with Life-Limiting and Life-Threatening Conditions: A Systematic Review Highlighting Meaningful Health Outcomes. Patient. 2019 Feb;12(1):15-55. doi: 10.1007/s40271-018-0333-5.
- Background: PubMed 28602938Bender HU, Riester MB, Borasio GD, Fuhrer M. "Let's Bring Her Home First." Patient Characteristics and Place of Death in Specialized Pediatric Palliative Home Care. J Pain Symptom Manage. 2017 Aug;54(2):159-166. doi: 10.1016/j.jpainsymman.2017.04.006. Epub 2017 Jun 8.
- Background: PubMed 29174080DeCourcey DD, Silverman M, Oladunjoye A, Balkin EM, Wolfe J. Patterns of Care at the End of Life for Children and Young Adults with Life-Threatening Complex Chronic Conditions. J Pediatr. 2018 Feb;193:196-203.e2. doi: 10.1016/j.jpeds.2017.09.078. Epub 2017 Nov 22.
- Background: PubMed 15050658Good PD, Cavenagh J, Ravenscroft PJ. Survival after enrollment in an Australian palliative care program. J Pain Symptom Manage. 2004 Apr;27(4):310-5. doi: 10.1016/j.jpainsymman.2003.12.011.
- Background: PubMed 21555495Feudtner C, Kang TI, Hexem KR, Friedrichsdorf SJ, Osenga K, Siden H, Friebert SE, Hays RM, Dussel V, Wolfe J. Pediatric palliative care patients: a prospective multicenter cohort study. Pediatrics. 2011 Jun;127(6):1094-101. doi: 10.1542/peds.2010-3225. Epub 2011 May 9.
- Background: PubMed 25157003Siden H, Chavoshi N, Harvey B, Parker A, Miller T. Characteristics of a pediatric hospice palliative care program over 15 years. Pediatrics. 2014 Sep;134(3):e765-72. doi: 10.1542/peds.2014-0381.
- Background: PubMed 16470155Mack JW, Wolfe J. Early integration of pediatric palliative care: for some children, palliative care starts at diagnosis. Curr Opin Pediatr. 2006 Feb;18(1):10-4. doi: 10.1097/01.mop.0000193266.86129.47.
- Background: PubMed 25694102Himmelmann K, Sundh V. Survival with cerebral palsy over five decades in western Sweden. Dev Med Child Neurol. 2015 Aug;57(8):762-7. doi: 10.1111/dmcn.12718. Epub 2015 Feb 19.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ashley RIDLEY, M.D. principal investigator
Assistance Publique - Hôpitaux de Paris
Hélène GEFFROY, Resident study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalopathy and Cerebral Palsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of first pediatric palliative care intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273267, which also lists 8 linked publications.
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 12 Sep 2025.