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Not yet recruiting NCT06960356

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

No phase Interventional Stress Disorder, Post Traumatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: detect post-traumatic stress disorder.
Who it may be relevant to
Registry conditions: Stress Disorder, Post Traumatic. Basic parameters: 1 year — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other 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

  • post-traumatic stress disorder [Time frame: 3 months]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06960356 · 38RC24.0249 · 2024-A01670-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗