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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06960356
Acronym
SURVIPED
Enrollment
115
Registered
2025-05-07
Start date
2025-12-31
Completion date
2025-12-31
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorder, Post Traumatic

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.

Interventions

OTHERdetect post-traumatic stress disorder

recommendation for follow-up by a professional specializing in child development and/or a complementary medical consultation

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
post-traumatic stress disorder3 monthsPrevalence 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

Secondary

MeasureTime frameDescription
Pediatric Quality of Life Inventory TM (PEDSQL scale)3 monthsassessing 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.
correlation between the PTSD score and the child's quality of life3 monthscorrelation 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)
Measurement of the association between the characteristics of children and their stay in critical care, and the presence of PTSD3 monthsSearch 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)
Evaluate the feasibility of having the follow-up critical care consultation carried out by a nursery nurse3 monthstime devoted to organising and carrying out consultations and referrals, number and proportion of parents who do not attend consultations (parental involvement)
Screening parents for PTSD3 monthsScreening 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
factors associated with the occurrence of PTSD in parents3 monthsMeasurement 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
number of children with significant somatic symptoms3 monthsEstimate the proportion of children presenting significant and disabling somatic symptoms in their lives, requiring referral to the appropriate healthcare professionals.

Contacts

Primary ContactAlice FUMAGALLI, PDE
AFumagalli@chu-grenoble.fr0676765503
Backup ContactGuillaume MORTAMET, PHD
Gmortamet@chu-grenoble.fr0476765503

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026