The NEU - CAP Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 32
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Born before 32 weeks of gestation
Received non-humidified face-mask support in the first 10 minutes of life
Parental consent obtained
Disqualifiers
Congenital diaphragmatic hernia
Tracheo-oesophageal fistula
Cyanotic heart disease
Surfactant protein deficiency
Trial design
Treatments tested in this trial
- Local standard care of monitoring non-invasive ventilation
- CO₂-guided Non-Invasive Ventilation
Treatment groups
1,860 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov