Delirium Assessment in the Pediatric Intensive Care Unit | NCT04041947

Studies
Delirium Assessment in the Pediatric Intensive Care Unit

NCT04041947

Sponsor

Cukurova University

Status

Completed

Last Update Posted

Feb 12, 2020Actual

Enrollment

140Actual

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Dec 1, 2019Actual

First Submitted Date

Jul 29, 2019

First Submission Date that Met QC Criteria

Jul 31, 2019

First Posted Date

Aug 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2020

Last Update Posted Date

Feb 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

The aim of this study was to show the efficacy of non-pharmacological interventions on preventing pediatric delirium in pediatric intensive care unit. Patients who is followed up for at least 48 hours in pediatric intensive care unit will be included in the study. Parents of patients will be allowed to stay with the patient as long as the conditions of service is appropriate. Parents will provide oral treatments to the patients. Patients will be allowed to spend time with their phone, tablet or toy in accordance with their age. Fellow resident will screen for pediatric delirium each child using the Cornell Assessment of Pediatric Delirium twice a day.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pediatric delirium frequency	The effect of non-pharmacological interventions on the prevalence of pediatric delirium	Up to a month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children in PICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dinçer Yildizdaş, Professor	Cukurova University Medicine Faculty	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cukurova University Medicine Faculty		Adana			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided