BronchiolitisNCT02913040
High Flow in Infants With Bronchiolitis
A study testing High Flow Nasal Cannula and Low Flow Nasal Prongs in people with Bronchiolitis, run by Princess Amalia Children's Clinic at 7 sites in Netherlands.
Trial summary
In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea. Read more about this study
- Who is it for?
- Ages 1 week to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- High Flow Nasal Cannula and Low Flow Nasal Prongs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 7 sitesNetherlands
- Study dates
- 1 Dec 2016to 1 May 2020
- 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 1 week to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- bronchiolitis PEWS (Pediatric Early Warning Score 0-28) >= 6 oxygen saturation < 92%
Who cannot join
- chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Amphia
Breda
Deventer Ziekenhuis
Deventer
Medisch Spectrum Twente
Enschede
Martini Ziekenhuis
Groningen
Canisius-Wilhelmina Ziekenhuis
Nijmegen
Ikazia Hospital
Rotterdam
Isala Klinieken
Zwolle, Overijssel, 8000 GK
About this study
Official title: High Flow Nasal Cannula Therapy for Infants With Bronchiolitis
In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea.
Read the detailed description
In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal Cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea. The study will take place on the pediatric (Non intensive care) units of 5 different hospitals in the Netherlands.
- Conditions
- Bronchiolitis
- Being tested
- High Flow Nasal Cannula, Low Flow Nasal Prongs
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaOther
Also called HFNC
Oxygen delivery through Heated Humidified High Flow Nasal Cannula
Low Flow Nasal ProngsOther
Also called LFNC
Oxygen delivery through Low Flow Nasal Prongs
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Oxygen delivery through Heated Humidified High Flow Nasal Cannula Receives: Other: High Flow Nasal Cannula |
| Low Flow Nasal Prongs | Active comparator | Oxygen delivery through Low Flow Nasal Prongs Receives: Other: Low Flow Nasal Prongs |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEWS (Pediatric Early Warning Score) (in points 0-28)
Sustained reduction in PEWS >= 2 points within 24 hours (min 0- max 28 points)
Measured: 24 hours
Secondary outcomes (4)
Comfort (in points 0-10)
(FLACC: Face, Legs, Activity, Cry, Consolability, min 0- max 10 points)
Measured: 24 hours
ability to feed (yes or no)
need for tubefeeding and/or intravenous fluids
Measured: 5 days
duration of hospitalisation in days
duration of hospitalisation in days
Measured: 15 days
admission to PICU (Pediatric Intensive Care Unit) (yes or no)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start1 Dec 2016
- Primary completion31 Mar 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Amalia Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jolita Bekhof, MD, PhD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913040
- Sponsor's protocol ID
- High Flow in Bronchiolitis
- Status last verified
- May 2020
- First submitted
- 17 Sep 2016
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: publication in journal
Publications
Kooiman L, Blankespoor F, Hofman R, Kamps A, Gorissen M, Vaessen-Verberne A, Heuts I, Bekhof J. High-flow oxygen therapy in moderate to severe bronchiolitis: a randomised controlled trial. Arch Dis Child. 2023 Jun;108(6):455-460. doi: 10.1136/archdischild-2022-324697. Epub 2023 Mar 20.
PubMed 36941030
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Therapy for Infants With Bronchiolitis
- ClinicalTrials.gov ID
- NCT02913040
- Acronym / sponsor ID
- High Flow in Bronchiolitis
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Princess Amalia Children's ClinicUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 23 Sep 2016 (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.
In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea.
Detailed description
In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal Cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea. The study will take place on the pediatric (Non intensive care) units of 5 different hospitals in the Netherlands.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Other: High Flow Nasal CannulaOxygen delivery through Heated Humidified High Flow Nasal Cannula |
| Low Flow Nasal Prongs | Active comparator | Other: Low Flow Nasal ProngsOxygen delivery through Low Flow Nasal Prongs |
Who may qualify
- Ages
- 1 week to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- bronchiolitis PEWS (Pediatric Early Warning Score 0-28) >= 6 oxygen saturation < 92%
Key exclusion criteria (1 listed)
- chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities
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 |
|---|---|---|
| High Flow Nasal CannulaAlso: HFNCOxygen delivery through Heated Humidified High Flow Nasal Cannula | Other | High Flow Nasal Cannula |
| Low Flow Nasal ProngsAlso: LFNCOxygen delivery through Low Flow Nasal Prongs | Other | Low Flow Nasal Prongs |
Primary outcome
PEWS (Pediatric Early Warning Score) (in points 0-28)
Time frame: 24 hours
Sustained reduction in PEWS >= 2 points within 24 hours (min 0- max 28 points)
4 secondary outcomes
Comfort (in points 0-10)
Time frame: 24 hours
ability to feed (yes or no)
Time frame: 5 days
duration of hospitalisation in days
Time frame: 15 days
admission to PICU (Pediatric Intensive Care Unit) (yes or no)
Time frame: 5 days
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 28 May 2020.
- Derived from this study: PubMed 36941030Kooiman L, Blankespoor F, Hofman R, Kamps A, Gorissen M, Vaessen-Verberne A, Heuts I, Bekhof J. High-flow oxygen therapy in moderate to severe bronchiolitis: a randomised controlled trial. Arch Dis Child. 2023 Jun;108(6):455-460. doi: 10.1136/archdischild-2022-324697. Epub 2023 Mar 20.
- Individual participant dataSharing planned: Yes. publication in journal
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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.
Jolita Bekhof, MD, PhD principal investigator
Isala
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula and Low Flow Nasal Prongs in people with Bronchiolitis, run by Princess Amalia Children's Clinic at 7 sites in Netherlands.
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 1 inclusion and 1 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 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. 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?
PEWS (Pediatric Early Warning Score) (in points 0-28) (time frame: 24 hours). 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 NCT02913040, which also lists 1 linked publication.
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 28 May 2020.