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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Newborn; Medical Device Discomfort
• Interventions: Device: Respiratory support HFNC; Device: Respiratory support NCPAP

• Registration Number: NCT01526226
• Lead Sponsor: University Hospital of North Norway

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-31
• Study Start: 2012-02
• Study First Posted: 2012-02-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HFNC	Respiratory support HFNC	High flow nasal cannula
nCPAP	Respiratory support HFNC	Nasal CPAP
nCPAP	Respiratory support NCPAP	Nasal CPAP
HFNC	Respiratory support NCPAP	High flow nasal cannula

Primary Outcome Measures

Name	Time	Method
Patient comfort (EDIN score)	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 Outcome Measures

Name	Time	Method
Noise	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.
Stress hormone response (salivary cortisol)	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.
Parental satisfaction	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.

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Norway