Clinical Trial

The NEU - CAP Trial

Study acronym: NEU-CAP
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07754032
Lead Sponsor Leiden University Medical Center
Conditions Infant, Premature, Diseases, Birth, Preterm, Respiratory Distress Neonatal
Enrollment 1,860 participants
Start Date 2027-01
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-10