Stress Disorder, Post TraumaticSURVIPEDNCT06960356
Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome
A study testing detect post-traumatic stress disorder in people with Stress Disorder, Post Traumatic, run by University Hospital, Grenoble.
Trial summary
The investigator hypothesize that, during an IPDE consultation 3 months after discharge from critical care, the investigator will identify PTSD in approximately one-third of children, and show an association between this syndrome and quality of life in children admitted to pediatric intensive care. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Stress Disorder, Post Traumatic
- What is being tested?
- detect post-traumatic stress disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2025
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged between 1 and 17.5 years at inclusion
- Having stayed in a paediatric intensive care unit in one of the 2 participating centers: Lyon or Grenoble
- Requiring mechanical ventilation (invasive or non-invasive) for more than 24 hours
Who cannot join
- Patients already under the care of a psychologist or psychiatrist
- patients who died during their stay in intensive care
- Patients who died between discharge and 3 months
- Patients suspected of abuse
- Patient and/or parent refusal to participate
- No social security affiliation
- Patients / parents who do not speak French
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The investigator hypothesize that, during an IPDE consultation 3 months after discharge from critical care, the investigator will identify PTSD in approximately one-third of children, and show an association between this syndrome and quality of life in children admitted to pediatric intensive care.
- Conditions
- Stress Disorder, Post Traumatic
- Being tested
- detect post-traumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detect post-traumatic stress disorderOther
recommendation for follow-up by a professional specializing in child development and/or a complementary medical consultation
| Study group | Role | What they receive |
|---|---|---|
| screening for post-resuscitation syndrome | Experimental | Not described Receives: Other: detect post-traumatic stress disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-traumatic stress disorder
Prevalence of post-traumatic stress disorder (PTSD) as defined by a standardized assessment of PTSD using the Children's Revised Impact of Event Scale (CRIES-13) scale for children over 7 years of age.
Range from 0 to 80. Higher scores indicate greater post-traumatic stress
Measured: 3 months
Secondary outcomes (7)
Pediatric Quality of Life Inventory TM (PEDSQL scale)
assessing Pediatric Quality of Life Inventory TM (PESQL scale) at 3 months in patients admitted to pediatric critical care. Range from 0 to 230.
Higher scores indicate better health related quality of life.
Measured: 3 months
correlation between the PTSD score and the child's quality of life
correlation between the post-traumatic stress disorder score (Using Children's Revised Impact of Event Scale - range from 0 to 65 - the higher the score, the greater the impact of the event on the child) and the child's quality of life ( Using Pediatric Quality of Life Inventory TM scale - range from 0 to 230 - higher scores indicate better health-related quality of life)
Measured: 3 months
Measurement of the association between the characteristics of children and their stay in critical care, and the presence of PTSD
Search for factors associated with the onset of PTSD. Measurement of the association between the characteristics of children and their stay in critical care, and the presence of PTSD (using the Children's Revised Impact of event Scale - Range from 0to 65 - the higher the score, the greater the impact of the event on the child)
Measured: 3 months
number of children with significant somatic symptoms
Estimate the proportion of children presenting significant and disabling somatic symptoms in their lives, requiring referral to the appropriate healthcare professionals.
Measured: 3 months
Screening parents for PTSD
Screening parents for PTSD using the POst-Traumatic stress disorder checklist version DSM-5 (PCL 5). range from 0 to 80 - the higher the score, the greater the post-traumatic stress
Measured: 3 months
factors associated with the occurrence of PTSD in parents
Measurement of the association between the characteristics of the children and their stay in critical care, and the presence of PTSD in the parents with Post-Traumatic stress disorder checklist version DSM-5 (PCL 5). range from 0 to 80 - the higher the score, the greater the post-traumatic stress
Measured: 3 months
Evaluate the feasibility of having the follow-up critical care consultation carried out by a nursery nurse
time devoted to organising and carrying out consultations and referrals, number and proportion of parents who do not attend consultations (parental involvement)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorder, Post TraumaticStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960356
- Sponsor's protocol ID
- 38RC24.0249
- Other IDs
- 2024-A01670-47
- Acronym
- SURVIPED
- Status last verified
- Jan 2025
- First submitted
- 13 Mar 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome
- ClinicalTrials.gov ID
- NCT06960356
- Acronym / sponsor ID
- SURVIPED / 38RC24.0249
- Conditions
- Stress Disorder, Post Traumatic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 May 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.
The investigator hypothesize that, during an IPDE consultation 3 months after discharge from critical care, the investigator will identify PTSD in approximately one-third of children, and show an association between this syndrome and quality of life in children admitted to pediatric intensive care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening for post-resuscitation syndrome | Experimental | Other: detect post-traumatic stress disorder |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged between 1 and 17.5 years at inclusion
- Having stayed in a paediatric intensive care unit in one of the 2 participating centers: Lyon or Grenoble
- Requiring mechanical ventilation (invasive or non-invasive) for more than 24 hours
Key exclusion criteria (7 listed)
- Patients already under the care of a psychologist or psychiatrist
- patients who died during their stay in intensive care
- Patients who died between discharge and 3 months
- Patients suspected of abuse
- Patient and/or parent refusal to participate
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 |
|---|---|---|
| detect post-traumatic stress disorderrecommendation for follow-up by a professional specializing in child development and/or a complementary medical consultation | Other | screening for post-resuscitation syndrome |
Primary outcome
post-traumatic stress disorder
Time frame: 3 months
Prevalence of post-traumatic stress disorder (PTSD) as defined by a standardized assessment of PTSD using the Children's Revised Impact of Event Scale (CRIES-13) scale for children over 7 years of age. Range from 0 to 80. Higher scores indicate greater post-traumatic stress
7 secondary outcomes
Pediatric Quality of Life Inventory TM (PEDSQL scale)
Time frame: 3 months
correlation between the PTSD score and the child's quality of life
Time frame: 3 months
Measurement of the association between the characteristics of children and their stay in critical care, and the presence of PTSD
Time frame: 3 months
number of children with significant somatic symptoms
Time frame: 3 months
Screening parents for PTSD
Time frame: 3 months
factors associated with the occurrence of PTSD in parents
Time frame: 3 months
Evaluate the feasibility of having the follow-up critical care consultation carried out by a nursery nurse
Time frame: 3 months
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 7 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing detect post-traumatic stress disorder in people with Stress Disorder, Post Traumatic, run by University Hospital, Grenoble.
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 3 inclusion and 7 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 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Alice FUMAGALLI, PDE (0676765503 ext. +33, AFumagalli@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-traumatic stress disorder (time frame: 3 months). 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 7 May 2025.