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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFNC | Experimental | High flow nasal cannula |
|
| nCPAP | Active Comparator | Nasal CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory support HFNC | Device | In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP |
|
| 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 |
| 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 |
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Inclusion Criteria:
Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study)
GA < 29 weeks: Respiratory "stable" over last 72 h.
GA 29-33 weeks: Respiratory "stable" over last 24 h.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Klingenberg, MD, PhD | University Hospital of North Norway, Tromsø, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway | Tromsø | N-9038 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21563154 | Background | Wilkinson D, Andersen C, O'Donnell CP, De Paoli AG. High flow nasal cannula for respiratory support in preterm infants. Cochrane Database Syst Rev. 2011 May 11;(5):CD006405. doi: 10.1002/14651858.CD006405.pub2. | |
| 24225220 | Derived | Klingenberg C, Pettersen M, Hansen EA, Gustavsen LJ, Dahl IA, Leknessund A, Kaaresen PI, Nordhov M. Patient comfort during treatment with heated humidified high flow nasal cannulae versus nasal continuous positive airway pressure: a randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F134-7. doi: 10.1136/archdischild-2013-304525. Epub 2013 Nov 13. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 27, 2020 | |
| Reset | Feb 13, 2020 | |
| Release | Jan 27, 2025 | |
| Reset | Feb 18, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 27, 2020 | Feb 13, 2020 | |||
| Jan 27, 2025 |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Respiratory support NCPAP | Device | In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP |
|
|
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) |
| Feb 18, 2025 |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |