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NCT Number: NCT01526226

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

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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Key information

Conditions

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

Age range

25 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, N-9038, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Respiratory support HFNC

Device

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

Other names: HFNC; Fisher and Paykel

Respiratory support NCPAP

Device

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

Other names: NCPAP: Infant Flow (CareFusion)

Primary outcomes

  1. 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

    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 outcomes

  1. Noise

    Time frame: 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.

  2. Parental satisfaction

    Time frame: 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.

  3. Stress hormone response (salivary cortisol)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2012
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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