[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651024":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":40,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":26,"maxAge":53,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard care","ACTIVE_COMPARATOR","At the start of the study, all participating centres will provide NIV using the standard monitoring methods in place as part of their local standard of care; this will not include using a CO₂ detector at any centre. No additional tools or changes to monitoring protocols will be introduced during this period.",[13],"Procedure: Local standard care of monitoring non-invasive ventilation",{"label":15,"type":16,"description":17,"interventionNames":18},"Colorimetric CO₂-detector-guided non-invasive ventilation","EXPERIMENTAL","For each centre, a lot will be drawn which indicates the fortnight in which the protocol changes from standard care to CO₂-detector-guided non-invasive ventilation.\n\nColorimetric CO₂ detectors have a chemical indicator that changes colour when a threshold level of CO₂ is exceeded. They are routinely used in newborn infants to confirm that an endotracheal tube (ETT) is correctly placed in the trachea. The CO₂ detector also has promise as a tool to directly assess lung aeration during mask breathing support. It could offer immediate feedback on both the adequacy of spontaneous breathing during continuous positive airway pressure (CPAP) and the effectiveness of PPV in non-breathing neonates. The colorimetric CO₂ detector used in this study has been developed specifically for use during NIV.\n\nAll other procedures in the delivery room and neonatal intensive care unit (NICU) will be performed according to international and local guidelines.",[19],"Procedure: CO₂-guided Non-Invasive Ventilation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Local standard care of monitoring non-invasive ventilation","See arm",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"CO₂-guided Non-Invasive Ventilation",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Mirthe M Bloemhof, MD","CONTACT","+31715298760","m.m.bloemhof@lumc.nl",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Janneke Dekker, PhD","+31715266620","j.dekker@lumc.nl",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Janneke Dekker","Assistant Professor","100651024","the-neu---cap-trial-100651024",false,"NCT07754032","The NEU - CAP Trial","A Randomised Trial of Colorimetric Carbon Dioxide (CO₂) Detector-guided Non-invasive Ventilation Versus Standard Care: The NEU-CAP Trial","NEU-CAP","Inclusion Criteria:\n\n* Born before 32 weeks of gestation\n* Received non-humidified face-mask support in the first 10 minutes of life\n* Parental consent obtained\n\nExclusion Criteria:\n\n* Congenital diaphragmatic hernia\n* Tracheo-oesophageal fistula\n* Cyanotic heart disease\n* Surfactant protein deficiency\n* Any other congenital abnormality or condition with an adverse effect on breathing, ventilation, or oxygenation. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.","ALL","32 Weeks",{"count":55,"type":56},1860,"ESTIMATED","INTERVENTIONAL",[59],"NA","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.",[62,63,64],"Infant, Premature, Diseases","Birth, Preterm","Respiratory Distress Neonatal",[66,67,68,69],"Resuscitation","Preterm infant","Non-invasive ventilation","CO₂-detection","NOT_YET_RECRUITING","2026-08-06",{"date":73,"type":74},"2026-08-10","ACTUAL",{"date":76,"type":56},"2027-01",{"date":78,"type":56},"2028-03",{"name":5,"class":6}]