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

University Hospital of North Norway

Status: Completed

Conditions: Medical Device Discomfort; Respiratory Distress Syndrome, Newborn

Treatments: Device: Respiratory support HFNC; Device: Respiratory support NCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01526226

2011-2019 REK NORD

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 25 to 34 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

HFNC

Experimental group

Description:

High flow nasal cannula

Treatment:

Device: Respiratory support NCPAP

Device: Respiratory support HFNC

nCPAP

Active Comparator group

Description:

Nasal CPAP

Treatment:

Device: Respiratory support NCPAP

Device: Respiratory support HFNC