BronchiolitisNCT03492307
Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial
A study testing Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) and Standard Flow for HFNC (Maximum 8L/minute) in people with Bronchiolitis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) and Standard Flow for HFNC (Maximum 8L/minute)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 30 Mar 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- admission to inpatient pediatrics
- clinical diagnosis of bronchiolitis
- BASS score of moderate or severe
Who cannot join
- non-english speakers
- patients with urgent need for CPAP, BIPAP or intubation
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.
Read the detailed description
This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.
- Conditions
- Bronchiolitis
- Being tested
- Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute), Standard Flow for HFNC (Maximum 8L/minute)
- Keywords
- High Flow Nasal Cannula
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)Other
A weight-based flow for HFNC.
Standard Flow for HFNC (Maximum 8L/minute)Other
Maximum flow of 8L/minute.
| Study group | Role | What they receive |
|---|---|---|
| Standard Flow Protocol | Active comparator | Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min. Receives: Other: Standard Flow for HFNC (Maximum 8L/minute) |
| Weight-Based Flow Protocol | Experimental | Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min. Receives: Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Need for escalation to NIV (CPAP or BIPAP) or intubation
Measured: During hospital admission
Length of Stay
Length of hospital stay (admission to discharge or transfer)
Measured: During hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 May 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 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.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South Shore Hospital
- Responsible party
- Principal investigator, Alla Smith, Boston Children's Hospital
- Investigators
- Alla Smith, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492307
- Sponsor's protocol ID
- IRB-P00028533
- Status last verified
- Jul 2021
- First submitted
- 3 Apr 2018
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith A, Banville D, O'Rourke C, Melvin P, Batey L, Borgmann A, Waltzman M, Agus MSD. Randomized Trial of Weight-Based Versus Fixed Limit High-Flow Nasal Cannula in Bronchiolitis. Hosp Pediatr. 2023 May 1;13(5):387-393. doi: 10.1542/hpeds.2022-006656.
PubMed 37122050
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03492307
- Acronym / sponsor ID
- IRB-P00028533
- Conditions
- Bronchiolitis
- Keywords
- High Flow Nasal Cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- South Shore Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 10 Apr 2018 (actual)
- 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.
This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.
Detailed description
This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Flow Protocol | Active comparator | Other: Standard Flow for HFNC (Maximum 8L/minute)Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min. |
| Weight-Based Flow Protocol | Experimental | Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- admission to inpatient pediatrics
- clinical diagnosis of bronchiolitis
- BASS score of moderate or severe
Key exclusion criteria (2 listed)
- non-english speakers
- patients with urgent need for CPAP, BIPAP or intubation
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 |
|---|---|---|
| Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)A weight-based flow for HFNC. | Other | Weight-Based Flow Protocol |
| Standard Flow for HFNC (Maximum 8L/minute)Maximum flow of 8L/minute. | Other | Standard Flow Protocol |
Primary outcome
Treatment failure
Time frame: During hospital admission
Need for escalation to NIV (CPAP or BIPAP) or intubation
Length of Stay
Time frame: During hospital admission
Length of hospital stay (admission to discharge or transfer)
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 29 Jul 2021.
- Derived from this study: PubMed 37122050Smith A, Banville D, O'Rourke C, Melvin P, Batey L, Borgmann A, Waltzman M, Agus MSD. Randomized Trial of Weight-Based Versus Fixed Limit High-Flow Nasal Cannula in Bronchiolitis. Hosp Pediatr. 2023 May 1;13(5):387-393. doi: 10.1542/hpeds.2022-006656.
- Individual participant dataSharing planned: No
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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.
Alla Smith, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) and Standard Flow for HFNC (Maximum 8L/minute) in people with Bronchiolitis, run by Boston Children's Hospital at 1 site in United States.
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 3 inclusion and 2 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 29 Jul 2021. 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 United States. 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?
Treatment failure (time frame: During hospital admission). The study lists 2 primary outcomes in all. 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 NCT03492307, 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 29 Jul 2021.