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

NCT05587595 | Unknown

• 2 other identifiers: APHP220341IDRCB: 2022-A00267-36
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Post-intensive Care Syndrome; Intensive Care Unit Syndrome

Keywords

critical care; PICS

Outcome Measures

Primary Outcomes (1)

• prevalence of children reporting Post Intensive Care Syndrome in pediatrics measured by questionnaire and medical record data collection

  questionnaire and medical record data collection

  4 months

Study Arms (2)

children with complicated sickle cell disease hospitalised in pediatric intensive care unit (PICU)

Other: questionnaires & data collection

children with complicated sickle cell disease hospitalised but not in intensive care unit

Other: questionnaires & data collection

Interventions

questionnaires & data collection OTHER

questionnaires

Also known as: questionnaires

children with complicated sickle cell disease hospitalised but not in intensive care unit; children with complicated sickle cell disease hospitalised in pediatric intensive care unit (PICU)

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children hospitalised (not planned) for asthma, SCD, sepsis in a tertiary pediatric hospital; with or without PICU care

You may qualify if:

• Children with a diagnosis of an acute complication of sickle cell disease such as acute chest syndrome or vaso-occlusive crisis, asthma attack or sepsis Unscheduled hospitalization at Robert Debré Hospital For more than 72 hours
• Ages 3 to 17

You may not qualify if:

• transfers (not possible to collect information the day before discharge)
• Participant unable or unwilling to comply with study procedures (including persons who do not speak French and cannot be assisted by a third party who speaks French)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires; Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michael LEVY, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael LEVY, MD, PhD

CONTACT

+33140034098; michael.levy@aphp.fr

Enora LE ROUX, PhD

CONTACT

+33140032366; enora.leroux@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: October 19, 2022
• Primary Completion: November 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 6, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)