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NCT Number: NCT06960356

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

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.

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Key information

Conditions

Stress Disorder, Post Traumatic Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

detect post-traumatic stress disorder

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Pediatric Quality of Life Inventory TM (PEDSQL scale)

    Time frame: 3 months

    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.

  2. correlation between the PTSD score and the child's quality of life

    Time frame: 3 months

    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. Measurement of the association between the characteristics of children and their stay in critical care, and the presence of PTSD

    Time frame: 3 months

    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)

  4. number of children with significant somatic symptoms

    Time frame: 3 months

    Estimate the proportion of children presenting significant and disabling somatic symptoms in their lives, requiring referral to the appropriate healthcare professionals.

  5. Screening parents for PTSD

    Time frame: 3 months

    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

  6. factors associated with the occurrence of PTSD in parents

    Time frame: 3 months

    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

  7. Evaluate the feasibility of having the follow-up critical care consultation carried out by a nursery nurse

    Time frame: 3 months

    time devoted to organising and carrying out consultations and referrals, number and proportion of parents who do not attend consultations (parental involvement)

Study contacts

Contact information is provided by the study sponsor or research team.

Alice FUMAGALLI, PDE

CONTACT

[email protected]

0676765503 ext. +33

Guillaume MORTAMET, PHD

CONTACT

[email protected]

0476765503 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: SURVIPED

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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