Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.

Pediatric Delirium Clinical Trial

Official title:

Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774211
• Other study ID #: NNF20OC0066074
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

• Pediatric intensive care patients

• Length of stay of 48 hours or more

Exclusion Criteria:

• Non Danish speaking

• Use of neuromuscular blocking agents

• sedation level at COMFORT behavior score > 11 or Richmond Agitation Sedation Scale > -3

Related Conditions & MeSH terms

• Delirium
• Pediatric Delirium

Intervention

Diagnostic Test:
• SOS-PD
Validation of SOS-PD bedside assessments comparing the Danish SOS-PD scale with a Child Psychiatrist using DSM-V as the reference standard

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The observation period is 24 hours
Secondary	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	The observation period is 24 hours