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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Distress Syndrome, Newborn, Medical Device Discomfort

Intervention / Treatment
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* Device: Respiratory support HFNC
* Device: Respiratory support NCPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study) Gestational age (GA) < 34 weeks Corrected age < 34 weeks Receiving nasal CPAP for respiratory distress Respiratory stable: FiO2 < 30%, pCO2 < 8,5 kPa and pH > 7.25. GA < 29 weeks: Respiratory stable over last 72 h. GA 29-33 weeks: Respiratory stable over last 24 h. Exclusion Criteria: Congenital anomalies Ongoing treatment for hypoglycemia or infection Other intercurrent disease requiring frequent blood sampling

Ages Eligible for Study
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Minimum Age: 25 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNC<br>High flow nasal cannula | Device: Respiratory support HFNC<br>* In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP<br>* Other names: HFNC; Fisher and Paykel;Device: Respiratory support NCPAP<br>* In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP<br>* Other names: NCPAP: Infant Flow (CareFusion);|
| Active Comparator: nCPAP<br>Nasal CPAP | Device: Respiratory support HFNC<br>* In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP<br>* Other names: HFNC; Fisher and Paykel;Device: Respiratory support NCPAP<br>* In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP<br>* Other names: NCPAP: Infant Flow (CareFusion);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort (EDIN score) | EDIN score (neonatal pain and comfort score) is a validated scoring system to assess pain and comfort in term and preterm infants. The cumulative EDIN score, based on three evaluations/24 h, is recorded for each 24 h epoch with HFNC or CPAP, respectively. The change in EDIN score between the two 24 h epochs are assessed. | 48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noise | Surrounding noise (dB)is measured twice daily during the 2 x 24 (48) h study period; twice during CPAP and twice during HFNC. | Measured at 10 AM and 10 PM over 48 h (4 measurements) | 
| Parental satisfaction | 3 questions related to parental satisfaction are asked by the end of each 24 h epoch with either CPAP or HFNC. | Three questions answered after 24 h and 48 h | 
| Stress hormone response (salivary cortisol) | Salivary cortisol is used as a marker of stress hormone response. Salivary cortisol is collected twice (10 AM and 10 PM) for every 24 h epoch; a total of 4 measurements. | Measured at 10 AM and 10 PM over 48 h (4 measurements) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High flow nasal cannula, Discomfort