BronchiolitisNCT03095495
High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue
A study testing Heated Humidified High Flow Nasal Cannula and Standard Therapy (Low Flow Nasal Cannula) in people with Bronchiolitis and Respiratory Syncytial Virus (RSV), run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Bronchiolitis, Respiratory Syncytial Virus (RSV)
- What is being tested?
- Heated Humidified High Flow Nasal Cannula and Standard Therapy (Low Flow Nasal Cannula)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteQatar
- Study dates
- 14 Aug 2018to 28 May 2024
- 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 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Previously healthy infants with age 0-3 months and gestational age ≥30 weeks admitted to the short stay unit with RSV positive bronchiolitis and clinical severity score ≥4 on Wang clinical severity scale.
Who cannot join
- Gestational age less than 30 weeks.
- Previous history of wheezing.
- Use of steroid within 48 hours of presentation.
- History of chronic lung disease.
- Infants admitted directly to ICU.
- Prior invasive or non-invasive ventilatory support.
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- Tracheostomy.
- Nasogastric tubes in situ on admission.
- Upper airway abnormality (like choanal atresia and midfacial anomalies).
- Immunodeficient children.
- History of cardiac disease, renal disease or liver disease.
- History of neuromuscular disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heated Humidified High Flow Nasal Cannula (HHHFNC) For Acute Moderate to Severe RSV-Bronchiolitis in Infants Younger Than 3 Months Old: Early Versus Rescue
The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment.
Read the detailed description
Setting:
The study will be conducted between June 2017 and June 2020 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis with positive RSV test will be eligible for the study.
Procedure:
Eligible patients will be enrolled after obtaining written consent. For patients who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized in one of the study arms. Adverse effects in each group will be carefully monitored and documented.
Study Intervention:
Patients will be randomized into two treatment arms
Group 1: Early HHHFNC Group Patients in this group will be treated by using heated humidified high flow oxygen /air via nasal cannula; investigators will keep the patient on HHHFNC until he/she becomes clinically ready for discharge.
Group 2: Standard Therapy and Rescue HHHFNC Group:
patients in this group will be treated by usual therapy,investigators will use low flow nasal cannula oxygen therapy only if oxygenation needed to maintain Oxygen saturation (SpO2) ≥ 92% , if the patient deteriorate and require ICU, rescue HHHFNC will be started before admission to the ICU.
- Conditions
- Bronchiolitis, Respiratory Syncytial Virus (RSV)
- Being tested
- Heated Humidified High Flow Nasal Cannula, Standard Therapy (Low Flow Nasal Cannula)
- Keywords
- Heated Humidified High Flow Nasal Cannula (HHHFNC), Low Flow Nasal Cannula, Bronchiolitis, Respiratory Syncytial Virus (RSV), Respiratory Failure, High Flow Nasal Cannula (HFNC), Lung Diseases, Obstructive
- Medical subject headings
- Bronchiolitis, Respiratory Insufficiency, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated Humidified High Flow Nasal CannulaDevice
HHHFNC therapy is a simple to use system that delivers warm and moist air/oxygen mixture at high flow rates that generate positive airway pressure
Standard Therapy (Low Flow Nasal Cannula)Device
will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU
| Study group | Role | What they receive |
|---|---|---|
| Early use of HHHFNC | Experimental | Heated Humidified High Flow Nasal Cannula Receives: Device: Heated Humidified High Flow Nasal Cannula |
| Standard Therapy and Rescue HHHFNC | Active comparator | Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU Receives: Device: Heated Humidified High Flow Nasal Cannula; Device: Standard Therapy (Low Flow Nasal Cannula) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Pediatric Intensive Care Unit (PICU) admissions
The rate of Pediatric Intensive Care Unit admissions
Measured: Through study completion, an average of 3 year
Secondary outcomes (5)
Mean length of stay (LOS)
Geometric mean length of stay in the short stay unit
Measured: Through study completion, an average of 3 year
Bronchiolitis Severity Score (BSS)
Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours
Measured: Up to 72 hours
Percentage of revisit, infirmary short-stay and admission to the hospital or PICU
Percentage of revisit, infirmary short-stay and admission to the hospital or PICU for the same illness on follow up for two weeks post discharge
Measured: 2 weeks after discharge
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours
Measured: Up to 72 hours
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED
Measured: 1 hour after starting of rescue HHHFNC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start14 Aug 2018
- Primary completion28 May 2024
- Study completion28 May 2024
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.
- More trials run by Hamad Medical CorporationThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sidra Medicine
- Responsible party
- Sponsor
- Investigators
- Khalid Alansari, MD, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095495
- Sponsor's protocol ID
- 16036/16
- Status last verified
- May 2024
- First submitted
- 6 Mar 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heated Humidified High Flow Nasal Cannula (HHHFNC) For Acute Moderate to Severe RSV-Bronchiolitis in Infants Younger Than 3 Months Old: Early Versus Rescue
- ClinicalTrials.gov ID
- NCT03095495
- Acronym / sponsor ID
- 16036/16
- Conditions
- Bronchiolitis, Respiratory Syncytial Virus (RSV)
- Keywords
- Heated Humidified High Flow Nasal Cannula (HHHFNC), Low Flow Nasal Cannula, Bronchiolitis, Respiratory Syncytial Virus (RSV), Respiratory Failure, High Flow Nasal Cannula (HFNC), Lung Diseases, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Sidra Medicine
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 29 Mar 2017 (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.
The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment.
Detailed description
Setting:
The study will be conducted between June 2017 and June 2020 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis with positive RSV test will be eligible for the study.
Procedure:
Eligible patients will be enrolled after obtaining written consent. For patients who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized in one of the study arms. Adverse effects in each group will be carefully monitored and documented.
Study Intervention:
Patients will be randomized into two treatment arms
Group 1: Early HHHFNC Group Patients in this group will be treated by using heated humidified high flow oxygen /air via nasal cannula; investigators will keep the patient on HHHFNC until he/she becomes clinically ready for discharge.
Group 2: Standard Therapy and Rescue HHHFNC Group:
patients in this group will be treated by usual therapy,investigators will use low flow nasal cannula oxygen therapy only if oxygenation needed to maintain Oxygen saturation (SpO2) ≥ 92% , if the patient deteriorate and require ICU, rescue HHHFNC will be started before admission to the ICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early use of HHHFNC | Experimental | Device: Heated Humidified High Flow Nasal CannulaHeated Humidified High Flow Nasal Cannula |
| Standard Therapy and Rescue HHHFNC | Active comparator | Device: Heated Humidified High Flow Nasal Cannula, Device: Standard Therapy (Low Flow Nasal Cannula)Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Previously healthy infants with age 0-3 months and gestational age ≥30 weeks admitted to the short stay unit with RSV positive bronchiolitis and clinical severity score ≥4 on Wang clinical severity scale.
Key exclusion criteria (12 listed)
- Gestational age less than 30 weeks.
- Previous history of wheezing.
- Use of steroid within 48 hours of presentation.
- History of chronic lung disease.
- Infants admitted directly to ICU.
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 |
|---|---|---|
| Heated Humidified High Flow Nasal CannulaHHHFNC therapy is a simple to use system that delivers warm and moist air/oxygen mixture at high flow rates that generate positive airway pressure | Device | Early use of HHHFNC, Standard Therapy and Rescue HHHFNC |
| Standard Therapy (Low Flow Nasal Cannula)will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU | Device | Standard Therapy and Rescue HHHFNC |
Primary outcome
The rate of Pediatric Intensive Care Unit (PICU) admissions
Time frame: Through study completion, an average of 3 year
The rate of Pediatric Intensive Care Unit admissions
5 secondary outcomes
Mean length of stay (LOS)
Time frame: Through study completion, an average of 3 year
Bronchiolitis Severity Score (BSS)
Time frame: Up to 72 hours
Percentage of revisit, infirmary short-stay and admission to the hospital or PICU
Time frame: 2 weeks after discharge
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)
Time frame: Up to 72 hours
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED
Time frame: 1 hour after starting of rescue HHHFNC
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 19 Sep 2024.
- 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.
Khalid Alansari, MD principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heated Humidified High Flow Nasal Cannula and Standard Therapy (Low Flow Nasal Cannula) in people with Bronchiolitis and Respiratory Syncytial Virus (RSV), run by Hamad Medical Corporation at 1 site in Qatar.
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 12 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 19 Sep 2024. 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 Qatar. 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?
The rate of Pediatric Intensive Care Unit (PICU) admissions (time frame: Through study completion, an average of 3 year). 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 19 Sep 2024.