NCT01526226

Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)

Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 25 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

Summary

Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked. The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort. The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations. The investigators plan to recruit 20 patients.

Conditions

• Respiratory Distress Syndrome, Newborn
• Medical Device Discomfort

Interventions

Type	Name	Description
DEVICE	Respiratory support HFNC	In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
DEVICE	Respiratory support NCPAP	In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-02-03
• Last updated: 2017-06-26

Locations

1 site across 1 country: Norway