- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041947
Delirium Assessment in the Pediatric Intensive Care Unit
February 11, 2020 updated by: Ahmet Yontem, Cukurova University
Assessment of Delirium Frequency and Risk Factors in Pediatric Intensive Care Unit
The aim of this study was to show the efficacy of non-pharmacological interventions on preventing pediatric delirium in pediatric intensive care unit
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Adana, Turkey
- Cukurova University Medicine Faculty
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children in PICU
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric delirium frequency
Time Frame: Up to a month
|
The effect of non-pharmacological interventions on the prevalence of pediatric delirium
|
Up to a month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dinçer Yildizdaş, Professor, Cukurova University Medicine Faculty
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
July 29, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (Actual)
August 1, 2019
Study Record Updates
Last Update Posted (Actual)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUTF-GOKAEK-82
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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