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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01526226
First received: January 2, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn
Medical Device Discomfort
Device: Respiratory support HFNC
Device: Respiratory support NCPAP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Patient comfort (EDIN score) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Noise [ Time Frame: Measured at 10 AM and 10 PM over 48 h (4 measurements) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Three questions answered after 24 h and 48 h ] [ Designated as safety issue: No ]
    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) [ Time Frame: Measured at 10 AM and 10 PM over 48 h (4 measurements) ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HFNC
High flow nasal cannula
Device: Respiratory support HFNC
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Other Name: HFNC; Fisher and Paykel
Device: Respiratory support NCPAP
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Other Name: NCPAP: Infant Flow (CareFusion)
Active Comparator: nCPAP
Nasal CPAP
Device: Respiratory support HFNC
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Other Name: HFNC; Fisher and Paykel
Device: Respiratory support NCPAP
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Other Name: NCPAP: Infant Flow (CareFusion)

  Eligibility

Ages Eligible for Study:   25 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526226

Locations
Norway
University Hospital of North Norway
Tromsø, Norway, N-9038
Sponsors and Collaborators
University Hospital of North Norway
Investigators
Principal Investigator: Claus Klingenberg, MD, PhD University Hospital of North Norway, Tromsø, Norway
  More Information

Publications:
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01526226     History of Changes
Other Study ID Numbers: 2011-2019 REK NORD
Study First Received: January 2, 2012
Last Updated: June 18, 2013
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:
High flow nasal cannula
Discomfort

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 17, 2014