Medical Device Discomfort, Respiratory Distress Syndrome, Newborn
Conditions
Keywords
High flow nasal cannula, Discomfort
Brief 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.
Interventions
DEVICERespiratory support HFNC
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
DEVICERespiratory support NCPAP
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Sponsors
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Weeks to 34 Weeks
Healthy volunteers
No
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
1. Congenital anomalies 2. Ongoing treatment for hypoglycemia or infection 3. Other intercurrent disease requiring frequent blood sampling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient comfort (EDIN score) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Noise | Measured at 10 AM and 10 PM over 48 h (4 measurements) | Surrounding noise (dB)is measured twice daily during the 2 x 24 (48) h study period; twice during CPAP and twice during HFNC. |
| Parental satisfaction | Three questions answered after 24 h and 48 h | 3 questions related to parental satisfaction are asked by the end of each 24 h epoch with either CPAP or HFNC. |
| Stress hormone response (salivary cortisol) | Measured at 10 AM and 10 PM over 48 h (4 measurements) | 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. |
Countries
Norway
Outcome results
None listed