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

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526226
• Other study ID #: 2011-2019 REK NORD
• Status: Completed
• Phase: N/A
• First received: January 2, 2012
• Last updated: June 23, 2017
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Medical Device Discomfort
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Respiratory support HFNC
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
• Respiratory support NCPAP
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. Review. Update in: Cochrane Database Syst Rev. 2016;2:CD006405. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Noise	Surrounding noise (dB)is measured twice daily during the 2 x 24 (48) h study period; twice during CPAP and twice during HFNC.	Measured at 10 AM and 10 PM over 48 h (4 measurements)
Secondary	Parental satisfaction	3 questions related to parental satisfaction are asked by the end of each 24 h epoch with either CPAP or HFNC.	Three questions answered after 24 h and 48 h
Secondary	Stress hormone response (salivary cortisol)	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.	Measured at 10 AM and 10 PM over 48 h (4 measurements)