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The NEU - CAP Trial
Sponsor: Leiden University Medical Center
Summary
The aim of NEU-CAP is to investigate the clinical impact of using a colorimetric carbon dioxide (CO₂) detector during non-invasive ventilation (NIV). Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioural aspect, in this case CO₂-detector-guided non-invasive ventilation.
Official title: A Randomised Trial of Colorimetric Carbon Dioxide (CO₂) Detector-guided Non-invasive Ventilation Versus Standard Care: The NEU-CAP Trial
Key Details
Gender
All
Age Range
Any - 32 Weeks
Study Type
INTERVENTIONAL
Enrollment
1860
Start Date
2027-01
Completion Date
2028-03
Last Updated
2026-08-10
Healthy Volunteers
No
Interventions
Local standard care of monitoring non-invasive ventilation
See arm
CO₂-guided Non-Invasive Ventilation
See arm