Pediatric DeliriumNCT04774211
Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.
An observational study of Pediatric Delirium, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Pediatric delirium (PD) is a poorly investigated clinical problem that needs to be further explored in a Danish context. Children are at risk of discomfort and suffering if they experience delirium. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Pediatric Delirium
- What is being tested?
- SOS-PD
- How many people
- 141 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 30 Jun 2022
- 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 3 months to 18 years
- All sexes
- Child, Adult
Study population: Pediatric intensive care patients
Who may be able to join
- Pediatric intensive care patients
- Length of stay of 48 hours or more
Who cannot join
- Non Danish speaking
- Use of neuromuscular blocking agents
- sedation level at COMFORT behavior score > 11 or Richmond Agitation Sedation Scale > -3
Trial locations and contacts
1 site in 1 country.
About this study
Pediatric delirium (PD) is a poorly investigated clinical problem that needs to be further explored in a Danish context. Children are at risk of discomfort and suffering if they experience delirium. The condition is associated with prolonged mechanical ventilation, longer hospital stay, increased mortality, and risk of long-term cognitive impairment. Therefore, it is important to assess critically ill children with a validated tool to enable early detection and management of the condition. In this study, the investigators will determine the prevalence of pediatric intensive care delirium. To this end, the investigators will validate the Sophia Observation withdrawal Symptoms - Pediatric delirium scale (SOS-PD) for patient assessment.
Read the detailed description
Prospective prevalence and validation study of pediatric intensive care delirium.
Aim: To validate the SOS-PD assessment tool and determine the prevalence of delirium in children aged 3 months to 18 years in a Danish context.
Data analysis and power calculation: With 140 patients, the accuracy estimate in this study will have a 95% confidence interval of +/- 5%. Accuracy defined as (true positive + true negative) / all x 100 is expected to be 90%. The validity of the SOS-PD assessment tool is calculated from standard definitions of sensitivity, specificity, positive predictive value and negative predictive value. The prevalence is calculated in percent. All data will be entered and encoded in RedCap and exported to SPSS for statistical analysis of data.
- Conditions
- Pediatric Delirium
- Being tested
- SOS-PD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOS-PDDiagnostic test
Validation of SOS-PD bedside assessments comparing the Danish SOS-PD scale with a Child Psychiatrist using DSM-V as the reference standard
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of delirium in children aged 3 months -18 years of age
Delirium prevalence is determined by the proportion of patients that had at least one positive delirium score with patients that never had a positive delirium score determined by Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD). The minimum score of SOS-PD is 0 and maximum score is 17. The score ≥4 indicates delirium.
Measured: The observation period is 24 hours
Secondary outcomes (1)
Validation of the Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD) assessment tool in to a Danish context.
The validity of the SOS-PD assessment tool is calculated from standard definitions of sensitivity, specificity, positive predictive value and negative predictive value
Measured: The observation period is 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DeliriumStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Rikke Louise Stenkjær, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Suzanne Forsyth Herling, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774211
- Sponsor's protocol ID
- NNF20OC0066074
- Status last verified
- Aug 2022
- First submitted
- 22 Feb 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.
- ClinicalTrials.gov ID
- NCT04774211
- Acronym / sponsor ID
- NNF20OC0066074
- Conditions
- Pediatric Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 Mar 2021 (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.
Pediatric delirium (PD) is a poorly investigated clinical problem that needs to be further explored in a Danish context. Children are at risk of discomfort and suffering if they experience delirium. The condition is associated with prolonged mechanical ventilation, longer hospital stay, increased mortality, and risk of long-term cognitive impairment. Therefore, it is important to assess critically ill children with a validated tool to enable early detection and management of the condition. In this study, the investigators will determine the prevalence of pediatric intensive care delirium. To this end, the investigators will validate the Sophia Observation withdrawal Symptoms - Pediatric delirium scale (SOS-PD) for patient assessment.
Detailed description
Prospective prevalence and validation study of pediatric intensive care delirium.
Aim: To validate the SOS-PD assessment tool and determine the prevalence of delirium in children aged 3 months to 18 years in a Danish context.
Data analysis and power calculation: With 140 patients, the accuracy estimate in this study will have a 95% confidence interval of +/- 5%. Accuracy defined as (true positive + true negative) / all x 100 is expected to be 90%. The validity of the SOS-PD assessment tool is calculated from standard definitions of sensitivity, specificity, positive predictive value and negative predictive value. The prevalence is calculated in percent. All data will be entered and encoded in RedCap and exported to SPSS for statistical analysis of data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric intensive care patients
Key inclusion criteria (2 listed)
- Pediatric intensive care patients
- Length of stay of 48 hours or more
Key exclusion criteria (3 listed)
- Non Danish speaking
- Use of neuromuscular blocking agents
- sedation level at COMFORT behavior score > 11 or Richmond Agitation Sedation Scale > -3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOS-PDValidation of SOS-PD bedside assessments comparing the Danish SOS-PD scale with a Child Psychiatrist using DSM-V as the reference standard | Diagnostic test | – |
Primary outcome
Prevalence of delirium in children aged 3 months -18 years of age
Time frame: The observation period is 24 hours
Delirium prevalence is determined by the proportion of patients that had at least one positive delirium score with patients that never had a positive delirium score determined by Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD). The minimum score of SOS-PD is 0 and maximum score is 17. The score ≥4 indicates delirium.
1 secondary outcome
Validation of the Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD) assessment tool in to a Danish context.
Time frame: The observation period is 24 hours
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 31 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Suzanne Forsyth Herling principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Pediatric Delirium, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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 31 Aug 2022. 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 Denmark. 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?
Prevalence of delirium in children aged 3 months -18 years of age (time frame: The observation period is 24 hours). 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 31 Aug 2022.