Clinical trial NCT01526226: Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)
Official title: Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Medical Device Discomfort
Keywords: High flow nasal cannula
Discomfort
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient comfort (EDIN score)
timeFrame: 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 outcomes:
measure: Noise
timeFrame: Measured at 10 AM and 10 PM over 48 h (4 measurements)
measure: Parental satisfaction
timeFrame: Three questions answered after 24 h and 48 h
measure: Stress hormone response (salivary cortisol)
timeFrame: Measured at 10 AM and 10 PM over 48 h (4 measurements)
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway, Tromsø, Norway
name: Claus Klingenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.