BronchiolitisPhase 4NCT03015051
High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis
A Phase 4 study testing Oxygen in people with Bronchiolitis, run by IRCCS Burlo Garofolo at 15 sites in Italy.
Trial summary
Bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 15 sitesItaly
- Study dates
- Jan 2017to Dec 2019
- Phase
- Phase 4
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of bronchiolitis
- age >28 days and <6 months
- Oxygen saturation (SaO2) <92%
- respiratory rate >60 breaths/min
- dyspnea with respiratory distress assessment instrument (RDAI) score ≥8
- daily milk or food intake less than 2/3 than normally assumed
Who cannot join
- chronic diseases or syndromes
- respiratory diseases (i.e. bronchopulmonary dysplasia)
- heart diseases
- preterm birth (before 36 weeks of gestational age)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Italy15 sites
Ospedale Maggiore
Bologna, Emilia-Romagna, 40133
Ospedale A. Cardarelli
Campobasso, Molise, 86170
Ospedale Morgagni-Pierantoni
Forlì, Emilia-Romagna, 47100
Istituto G. Gaslini
Genoa, Liguria, 16120
Fondazione MBBM c/o Ospedale San Gerardo
Monza, Lombardy, 20900
Ospedale Giovanni Paolo II
Olbia, Sardinia, 07026
Azienda Ospedaliera di Padova
Padova, Veneto, 35100
Ospedale Santa Maria degli Angeli
Pordenone, Friuli Venezia Giulia, 33170
Ospedale Provinciale di Macerata
Province of Macerata, The Marches, 62100
Ospedale Ravenna AUSL Romagna
Ravenna, Emilia-Romagna, 48100
Ospedale Pediatrico IRCCS Bambino Gesú
Rome, Lazio, 00165
Ospedale Principe di Piemonte Area Vasta 2
Senigallia, The Marches, 60019
Pediatric Emergency Department, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, 34137
Ospedale Infantile Regina Margherita
Turin, Piedmont, 10100
Ospedale Castelli
Verbania, Piedmont, 28992
About this study
Official title: Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis
Bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of the techniques of administration of oxygen in bronchiolitis is represented by the high flow (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces breathing load and allows for better nutrition. The main aim of therapy with high flows is to reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot study of 19 subjects comparing HFNC with oxygen administered via "head box". The oxygen saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs 96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available evidence is insufficient to determine the effectiveness of HFNC.
The aim of this study is to evaluate in a large number of cases the effectiveness of treatment with high flow versus standard treatment, in children with bronchiolitis referred to a Pediatric Emergency Department.
- Conditions
- Bronchiolitis
- Being tested
- Oxygen
- Keywords
- Bronchiolitis, High flow nasal cannula, Oxygen therapy
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
| Study group | Role | What they receive |
|---|---|---|
| High flow | Experimental | High flow (2 L/kg/min) nasal cannula oxygen therapy Receives: Drug: Oxygen |
| Low flow | Active comparator | Low flow (max 3 L/min) oxygen therapy Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours of oxygen therapy
Measured: up to 5 days
Secondary outcomes (4)
Number of subject admitted in intensive care unit
Measured: up to 5 days
Number of patients needing intubation
Measured: up to 5 days
Days of parenteral hydration or nasogastric enteral feeding
Number of days
Measured: up to 5 days
Adverse events
Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: Difficulty in recruiting subjects who meet the inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ronfani, IRCCS Burlo Garofolo
- Investigators
- Egidio Barbi, MD, Study chair, IRCCS Burlo Garofolo, Trieste, ItalyStefania Norbedo, MD, Study director, IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015051
- Sponsor's protocol ID
- High flow RCT
- Status last verified
- Sep 2020
- First submitted
- 24 Nov 2016
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis
- ClinicalTrials.gov ID
- NCT03015051
- Acronym / sponsor ID
- High flow RCT
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, High flow nasal cannula, Oxygen therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting subjects who meet the inclusion/exclusion criteria
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 9 Jan 2017 (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.
Bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of the techniques of administration of oxygen in bronchiolitis is represented by the high flow (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces breathing load and allows for better nutrition. The main aim of therapy with high flows is to reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot study of 19 subjects comparing HFNC with oxygen administered via "head box". The oxygen saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs 96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available evidence is insufficient to determine the effectiveness of HFNC.
The aim of this study is to evaluate in a large number of cases the effectiveness of treatment with high flow versus standard treatment, in children with bronchiolitis referred to a Pediatric Emergency Department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow | Experimental | Drug: OxygenHigh flow (2 L/kg/min) nasal cannula oxygen therapy |
| Low flow | Active comparator | Drug: OxygenLow flow (max 3 L/min) oxygen therapy |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- diagnosis of bronchiolitis
- age >28 days and <6 months
- Oxygen saturation (SaO2) <92%
- respiratory rate >60 breaths/min
- dyspnea with respiratory distress assessment instrument (RDAI) score ≥8
Key exclusion criteria (4 listed)
- chronic diseases or syndromes
- respiratory diseases (i.e. bronchopulmonary dysplasia)
- heart diseases
- preterm birth (before 36 weeks of gestational age)
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 |
|---|---|---|
| Oxygen | Drug | High flow, Low flow |
Primary outcome
Hours of oxygen therapy
Time frame: up to 5 days
4 secondary outcomes
Number of subject admitted in intensive care unit
Time frame: up to 5 days
Number of patients needing intubation
Time frame: up to 5 days
Days of parenteral hydration or nasogastric enteral feeding
Time frame: up to 5 days
Adverse events
Time frame: up to 15 days
Results and safety
The study was stopped early (reason given: Difficulty in recruiting subjects who meet the inclusion/exclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Egidio Barbi, MD study chair
IRCCS Burlo Garofolo, Trieste, Italy
Stefania Norbedo, MD study director
IRCCS Burlo Garofolo, Trieste, Italy
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen in people with Bronchiolitis, run by IRCCS Burlo Garofolo at 15 sites in Italy.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting subjects who meet the inclusion/exclusion criteria). Results are not available in the source record.
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?
Hours of oxygen therapy (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2020.