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

NCT01526226 | Completed

• 1 other identifier: 2011-2019 REK NORD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Newborn; Medical Device Discomfort

Keywords

High flow nasal cannula; Discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Noise

  Measured at 10 AM and 10 PM over 48 h (4 measurements)

• Parental satisfaction

  Three questions answered after 24 h and 48 h

• Stress hormone response (salivary cortisol)

  Measured at 10 AM and 10 PM over 48 h (4 measurements)

Study Arms (2)

HFNC

EXPERIMENTAL

High flow nasal cannula

Device: Respiratory support HFNC; Device: Respiratory support NCPAP

nCPAP

ACTIVE COMPARATOR

Nasal CPAP

Device: Respiratory support HFNC; Device: Respiratory support NCPAP

Interventions

Respiratory support HFNC DEVICE

In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP

Also known as: HFNC; Fisher and Paykel

HFNC; nCPAP

Respiratory support NCPAP DEVICE

In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP

Also known as: NCPAP: Infant Flow (CareFusion)

HFNC; nCPAP

Eligibility Criteria

• Age: 25 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Congenital anomalies
• Ongoing treatment for hypoglycemia or infection
• Other intercurrent disease requiring frequent blood sampling

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, N-9038, Norway

Location

Related Publications (2)

• 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.

  PMID: 21563154 BACKGROUND

• 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.

  PMID: 24225220 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Claus Klingenberg, MD, PhD

  University Hospital of North Norway, Tromsø, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: February 3, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 26, 2017

Record last verified: 2013-06

Locations

NO (1)