NCT04041947

Brief Summary

The aim of this study was to show the efficacy of non-pharmacological interventions on preventing pediatric delirium in pediatric intensive care unit

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

July 29, 2019

Last Update Submit

February 11, 2020

Conditions

Delirium

Keywords

DeliriumPediatric intensive care

Outcome Measures

Primary Outcomes (1)

  • Pediatric delirium frequency

    The effect of non-pharmacological interventions on the prevalence of pediatric delirium

    Up to a month

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children in PICU

You may qualify if:

  • Pediatric Cerebral Performance Category \< 5 points
  • Patients who stay in PICU \>48 hours

You may not qualify if:

  • Pediatric Cerebral Performance Category \> 4 points
  • Patients who stay in PICU \<48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Medicine Faculty

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dinçer Yildizdaş, Professor

    Cukurova University Medicine Faculty

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 1, 2019

Study Start

November 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

TU(1)