DeliriumNCT04041947
Delirium Assessment in the Pediatric Intensive Care Unit
An observational study of Delirium, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to show the efficacy of non-pharmacological interventions on preventing pediatric delirium in pediatric intensive care unit Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Delirium
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children in PICU
Who may be able to join
- Pediatric Cerebral Performance Category < 5 points
- Patients who stay in PICU >48 hours
Who cannot join
- Pediatric Cerebral Performance Category > 4 points
- Patients who stay in PICU <48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Delirium
- Keywords
- Delirium, Pediatric intensive care
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric delirium frequency
The effect of non-pharmacological interventions on the prevalence of pediatric delirium
Measured: Up to a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Nov 2018
- Primary completion1 Sep 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Yontem, Cukurova University
- Investigators
- Dinçer Yildizdaş, Professor, Study chair, Cukurova University Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041947
- Sponsor's protocol ID
- CUTF-GOKAEK-82
- Status last verified
- Feb 2020
- First submitted
- 29 Jul 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Delirium Frequency and Risk Factors in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04041947
- Acronym / sponsor ID
- CUTF-GOKAEK-82
- Conditions
- Delirium
- Keywords
- Delirium, Pediatric intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children in PICU
Key inclusion criteria (2 listed)
- Pediatric Cerebral Performance Category < 5 points
- Patients who stay in PICU >48 hours
Key exclusion criteria (2 listed)
- Pediatric Cerebral Performance Category > 4 points
- Patients who stay in PICU <48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pediatric delirium frequency
Time frame: Up to a month
The effect of non-pharmacological interventions on the prevalence of pediatric delirium
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinçer Yildizdaş, Professor study chair
Cukurova University Medicine Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric delirium frequency (time frame: Up to a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.