NCT06363344: APRELAREA

Follow-up in Pediatric Intensive Care Unit

Status unknown NA Last updated 15 April 2024

What this trial tests

NA trial testing Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999) in Intensive Care Psychosis in 120 participants. Status unknown.

Timeline

1 April 2024

Primary endpoint
1 April 2025

1 September 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	120
Start date	1 April 2024
Primary completion	1 April 2025
Estimated completion	1 September 2025
Sites	1 location across France

Drugs / interventions tested

• Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999)

Conditions studied

• Intensive Care Psychosis — all drugs for Intensive Care Psychosis →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 1 Day to 18, any sex, with Intensive Care Psychosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and thus, most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological, social and/or physical disorders) associated with their intensive care stay. Currently in France, there are no recommendations for the management of these patients and most of them do not have standardized follow-up.

Objectives Main objective: To assess the feasibility of implementing systematic and comprehensive management of pediatric patients who have been admitted to the PICU.

Intermediate objectives are to study:

* The needs of the children and their families which should be met by this management
* The acceptability of this organizational innovation for all the actors involved
* The cooperation between actors of the hospital and city health system + social professionals involved
* The costs of implementation and the budgetary impact of such a system

Methods Needs assessment: questionnaires and interviews with patients and their families (parents and possibly siblings if involved) to collect the medico-psycho-social impact of the PICU stay at the time of discharge and 3 months later.

Study of acceptability: quantitative survey of health professionals involved in the care of these children and expected care modalities. This includes pediatric intensivists, professionals from the children's usual care services (if applicable), attending physician.

Study of cooperation: analysis of needs and of the network usually solicited for the children benefiting from this care: who is identified, who remains to be identified, obstacles. Quantitative analysis of consultation reports and survey of professionals.

Budgetary impact analysis: study of the cost of setting up consultations for the health care system, and study of its financial and health consequences for the main needs identified, on the basis of data from the literature and expert opinions

Perspectives Compare the benefit of this systematic, multi professional and comprehensive management of pediatric patients after PICU discharge versus standard of care

Publications & conference data

No peer-reviewed publications indexed yet for this trial.