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

NCT06960356 | Not Yet Recruiting DMC

• 2 other identifiers: 38RC24.02492024-A01670-47
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress Disorder, Post Traumatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pediatric Quality of Life Inventory TM (PEDSQL scale)

  3 months

• correlation between the PTSD score and the child's 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

  3 months

• number of children with significant somatic symptoms

  3 months

• Screening parents for PTSD

  3 months

Study Arms (1)

screening for post-resuscitation syndrome

EXPERIMENTAL

Other: detect post-traumatic stress disorder

Interventions

detect post-traumatic stress disorder OTHER

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

screening for post-resuscitation syndrome

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Alice FUMAGALLI, PDE

CONTACT

0676765503; AFumagalli@chu-grenoble.fr

Guillaume MORTAMET, PHD

CONTACT

0476765503; Gmortamet@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: May 7, 2025
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-01