NCT05587595: Presage-SPSI

Transition From Paediatric Intensive Care to General Paediatrics and Pneumology Units : a Study of the Post-intensive Care Syndrome

Status unknown Last updated 6 February 2023

What this trial tests

trial testing questionnaires & data collection in Pediatric Post-intensive Care Syndrome in 80 participants. Status unknown.

Timeline

19 October 2022

Primary endpoint
1 November 2023

1 March 2024

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	80
Start date	19 October 2022
Primary completion	1 November 2023
Estimated completion	1 March 2024
Sites	1 location across France

Drugs / interventions tested

• questionnaires & data collection

Conditions studied

• Pediatric Post-intensive Care Syndrome — all drugs for Pediatric Post-intensive Care Syndrome →
• Intensive Care Unit Syndrome — all drugs for Intensive Care Unit Syndrome →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 3 to 17, any sex, with Pediatric Post-intensive Care Syndrome or Intensive Care Unit Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological and/or physical impairment) associated with their PICU stay and there is increasing awareness of the onset of post-intensive care syndromes (PICS) like in adults. However comprehensive descriptive data are still lacking regarding PICS in pediatrics (PICS-p).

The aim of this study is to describe (in nature and frequency) the alterations in health defined by the WHO of children who have passed through the PICU and constitute a possible PICS-p.

In order to do this, we will perform a prospective cohort study in Robert-Debré University Hospital including the PICU. We will include children with an unplanned hospitalization for more than 72 hours for acute complication of sickle cell disease (such as acute chest syndrome or vaso-occlusive crisis), acute asthma or sepsis and aged from 3 to 17 years. We plan to include 40 patients admitted to the PICU as well as 40 controls admitted to the general pediatrics unit or the pneumology unit without PICU admission, matched on diagnosis, age range and period.

The primary endpoint will be the prevalence of children that had been admitted to PICU and reporting cognitive, psychological, physical and social impairments measured by questionnaire and medical record data collection on the day before discharge and at the routine post-hospitalization visit.

Secondary objectives will be to study the risk factors for PICS-p, to compare alterations in cognitive, psychological, physical and social domains in children with the same diagnosis and age not admitted to the PICU during their hospitalization.

In order to this, we will measure the association with the PICU stay characteristics, parental experience and social characteristics of families. We will also report the prevalence of children not admitted in intensive care and reporting cognitive, psychological, physical and social impairments measured by questionnaire and medical record data collection on the day before discharge and at the routine post-hospitalization visit.

Patients and their parents will be given questionnaires the day before discharge and during the first follow-up consultation between 2 and 4 months after hospital discharge.

Questionnaires will include the Pediatric Symptom Checklist long version (Assessment of cognitive, psychological and social domains - 35 items scored from 0 to 2) reported by parents for children under 8 years and by the patients for children older than 8 years. older), the physical items of Pediatric Quality of Life scale (8 items scored from 0 to 4) and a parent self-questionnaire (including relationship to child, annual income, household composition, understanding and use of the French language, highest diploma of mother and father, social support (""How many people can you really count on when you need help?"")) and a parental mental health self-assessment (PHQ-8).

The analyses will be descriptive (description of the nature and frequency of alterations) and comparative (between children who have or have not been in PICU). Univariate tests will be performed to identify possible risk factors for post intensive care syndrome. Statistics will be carried out on SAS 9.4 software.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.