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Development of a simple sleep classification system for the pediatric intensive care unit

Development of a simple sleep classification system for the pediatric intensive care unit - SleePICU

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57572
Enrollment
Unknown
Registered
2025-05-22
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep pattern

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: - Patients admitted to the PICU and expected to be mechanically ventilated for more than 24 hours below 2 years of age. - Connected to the CFM monitor

Exclusion criteria

Exclusion criteria: - Premature birth with gestational age corrected for post-conceptional age less than 40 weeks. - Congenital or acquired neuromuscular disorders. - Congenital or acquired central nervous system disorders. - Severe traumatic brain injury (i.e. Glasgow Coma Scale

Design outcomes

Primary

MeasureTime frame
The ICC between sleep depth parameters measured from PSG, the gold standard, and the EEG signal from the CFM.

Secondary

MeasureTime frame
- The ICC, F-score and Cohen*s kappa between sleep states measured from PSG, the gold standard, and our newly designed classification system for different sleep classifications: - The ICC between different sleep characteristics between the PSG and the created classification system

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)