NCT04954261

Brief Summary

The purpose of this study is to introduce delirium detection and try to determine the prevalence of delirium in Pediatric Intensive Care Unit (PICU) using a validated tool : the Cornell Assessment of Pediatric Delirium (CAPD) for every patient twice a day.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 6, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2018

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

September 7, 2018

Last Update Submit

March 10, 2026

Conditions

Delirium

Keywords

Deliriumpaediatric intensive care unitCAPD (Cornell Assessment of Paediatric Delirium)French translation

Outcome Measures

Primary Outcomes (1)

  • Prevalence of delirium in the PICU population

    Number of CAPD evaluated \> 9 / total number of CAPD evaluated

    2 months

Secondary Outcomes (18)

  • Applicability of the CAPD by the paramedics

    Before inclusion period

  • Applicability of the CAPD by the paramedics after the 2 months period

    2 months

  • Use of the CAPD by the paramedics

    2 months

  • Age

    2 months

  • Sex

    2 months

  • +13 more secondary outcomes

Interventions

CAPDDIAGNOSTIC_TEST

CAPD evaluation every day per 12hours during their stay in PICU

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 0 to 18 years hospitalized in PICU at Necker Children's Hospital

You may qualify if:

  • Age 0 to 18 years old

You may not qualify if:

  • Patient with a state of sedation that does not allow the assessment of a change in the state of consciousness or cognitive functioning (equivalent score Richmond Agitation-Sedation Scale RASS \<-3 or COMFORT B \<11)
  • Patient or Parental opposition to the observational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Enfants Malades Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Laure De Saint Blanquat, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

July 8, 2021

Study Start

December 6, 2018

Primary Completion

December 6, 2018

Study Completion

December 6, 2018

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

FR(1)