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Clinical Trial NCT06960356 (SURVIPED) for Stress Disorder, Post Traumatic is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome (SURVIPED) 115 Pediatric

Not yet recruiting
Clinical Trial NCT06960356 (SURVIPED) is an interventional study for Stress Disorder, Post Traumatic and is currently not yet recruiting. Enrollment is planned to begin on December 1, 2025 and continue until the study accrues 115 participants. Led by University Hospital, Grenoble, this study is expected to complete by December 1, 2025. The latest data from ClinicalTrials.gov was last updated on May 7, 2025.
Brief 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.
Official Title

Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome

Conditions
Stress Disorder, Post Traumatic
Other Study IDs
  • SURVIPED
  • 38RC24.0249
  • 2024-A01670-47 (Other Identifier) (RCB)
NCT ID Number
NCT06960356
Start Date (Actual)
2025-12
Last Update Posted
2025-05-07
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
115
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalscreening for post-resuscitation syndrome
detect post-traumatic stress disorder
recommendation for follow-up by a professional specializing in child development and/or a complementary medical consultation
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
3 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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)
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)
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.
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
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
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)
3 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
1 Year
Eligible Sexes
All
  • 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

  • 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
University Hospital, Grenoble logoUniversity Hospital, Grenoble
Study Central Contact
Contact: Alice FUMAGALLI, PDE, 0676765503, [email protected]
Contact: Guillaume MORTAMET, PHD, 0476765503, [email protected]
No location data.