Respiratory Distress Syndrome, NewbornNCT01526226
Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)
A study testing Respiratory support HFNC and Respiratory support NCPAP in people with Respiratory Distress Syndrome, Newborn and Medical Device Discomfort, run by University Hospital of North Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 25 to 34 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Medical Device Discomfort
- What is being tested?
- Respiratory support HFNC and Respiratory support NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Congenital anomalies
- Ongoing treatment for hypoglycemia or infection
- Other intercurrent disease requiring frequent blood sampling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
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.
Read more
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.
- Being tested
- Respiratory support HFNC, Respiratory support NCPAP
- Keywords
- High flow nasal cannula, Discomfort
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory support HFNCDevice
Also called HFNC; Fisher and Paykel
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Respiratory support NCPAPDevice
Also called NCPAP: Infant Flow (CareFusion)
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
| Study group | Role | What they receive |
|---|---|---|
| HFNC | Experimental | High flow nasal cannula Receives: Device: Respiratory support HFNC; Device: Respiratory support NCPAP |
| nCPAP | Active comparator | Nasal CPAP Receives: Device: Respiratory support HFNC; Device: Respiratory support NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Surrounding noise (dB)is measured twice daily during the 2 x 24 (48) h study period; twice during CPAP and twice during HFNC.
Measured: Measured at 10 AM and 10 PM over 48 h (4 measurements)
Parental satisfaction
3 questions related to parental satisfaction are asked by the end of each 24 h epoch with either CPAP or HFNC.
Measured: Three questions answered after 24 h and 48 h
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: Measured at 10 AM and 10 PM over 48 h (4 measurements)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Klingenberg, MD, PhD, Principal investigator, University Hospital of North Norway, Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526226
- Sponsor's protocol ID
- 2011-2019 REK NORD
- Status last verified
- Jun 2013
- First submitted
- 2 Jan 2012
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21563154Klingenberg 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.
PubMed 24225220
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
- ClinicalTrials.gov ID
- NCT01526226
- Acronym / sponsor ID
- 2011-2019 REK NORD
- Keywords
- High flow nasal cannula, Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC | Experimental | Device: Respiratory support HFNC, Device: Respiratory support NCPAPHigh flow nasal cannula |
| nCPAP | Active comparator | Device: Respiratory support HFNC, Device: Respiratory support NCPAPNasal CPAP |
Who may qualify
- Ages
- 25 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study)
- GA < 29 weeks: Respiratory "stable" over last 72 h.
- GA 29-33 weeks: Respiratory "stable" over last 24 h.
Key exclusion criteria (3 listed)
- Congenital anomalies
- Ongoing treatment for hypoglycemia or infection
- Other intercurrent disease requiring frequent blood sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory support HFNCAlso: HFNC; Fisher and PaykelIn the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP | Device | HFNC, nCPAP |
| Respiratory support NCPAPAlso: NCPAP: Infant Flow (CareFusion)In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP | Device | HFNC, nCPAP |
Primary outcome
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.
3 secondary outcomes
Noise
Time frame: Measured at 10 AM and 10 PM over 48 h (4 measurements)
Parental satisfaction
Time frame: Three questions answered after 24 h and 48 h
Stress hormone response (salivary cortisol)
Time frame: Measured at 10 AM and 10 PM over 48 h (4 measurements)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Background: PubMed 21563154Wilkinson 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.
- Derived from this study: PubMed 24225220Klingenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Klingenberg, MD, PhD principal investigator
University Hospital of North Norway, Tromsø, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory support HFNC and Respiratory support NCPAP in people with Respiratory Distress Syndrome, Newborn and Medical Device Discomfort, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01526226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.