BronchiolitisHHFNCNCT01662544
Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia
A study testing Oxygen delivery in people with Bronchiolitis and Hypoxia, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and children. Multiple supportive therapies have been tried in infants with bronchiolitis including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date supportive therapy with oxygen is the only proven therapy… Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Bronchiolitis, Hypoxia
- What is being tested?
- Oxygen delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2017
- 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 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Are previously healthy infants ages 3 months to 18 months of age
- Have O2 saturations of < 92% on room air while awake
- Have a clinical diagnosis of bronchiolitis
- Have a CSS score showing moderate distress >4
- Have a planned admission to the hospital for either inpatient or observation status
- Have parental consent to enroll in study
Who cannot join
- Have significant apnea or bradycardia events reported by parent or witnessed in Emergency Department
- Have prior airway disease diagnosis other than URI within the previous two months
- Were previously intubated; previously having had airway bronchoscopy or surgery
- They are ex-preemies, i.e. had an estimated gestational age of <37 weeks at time of birth
- Have a diagnosis of lobar consolidation or round pneumonia by Chest x-ray
- Have pleural disease by chest x-ray
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- Have history of cardiac disease, renal disease, hematologic disease such as sickle cell disease or leukemia, congenital hemoglobinopathies or Congenital Adrenal Hyperplasia
- Have undergone prior radiation or chemotherapy
- Have functional or anatomical bowel obstruction as demonstrated by persistent vomiting or tensely distended abdomen
- Have history of Choanal atresia or cleft palate
- Have history of neuromuscular disorder, e.g., Spinal muscular atrophy, muscular dystrophies, cerebral palsy or hypotonia
- Have impending respiratory failure as demonstrated by blood gas with pCO2 of greater than 60 or apnea spells lasting greater than 30 seconds
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
About this study
Official title: Comparison of Heated Humidified High-flow Nasal Cannula (HHFNC) Versus Standard Nasal Cannula Oxygen Delivery on Respiratory Distress and Length of Stay in Infants With Bronchiolitis and Hypoxia
Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and children. Multiple supportive therapies have been tried in infants with bronchiolitis including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date supportive therapy with oxygen is the only proven therapy to decrease respiratory distress in infants with bronchiolitis, with hypertonic saline showing a borderline statistically significant improvement. This prospective, randomized study will compare CSS and PEWS scores on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen via Humidified High-Flow Nasal Cannula (HHFNC). The results will help determine if infants with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have improved Clinical Severity Score (CSS) and Pediatric Early Warning System (PEWS) scores and ultimately decreased lengths of admissions when compared to patients treated with nasal cannula oxygen therapy with/without bronchodilator therapy.
Hypothesis Heated Humidified High-flow Nasal Cannula Delivery of Oxygen decreases respiratory distress as measured by pediatric CSS and PEWS when compared with routine nasal cannula oxygen delivery in infants with bronchiolitis.
- Conditions
- Bronchiolitis, Hypoxia
- Being tested
- Oxygen delivery
- Keywords
- Infants, Bronchiolitis, Hypoxia, Emergency Department, Length of Stay, Pediatrics
- Medical subject headings
- Bronchiolitis, Hypoxia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen deliveryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HHFNC | Experimental | Heated High Flow arm Receives: Procedure: Oxygen delivery |
| Standard Nasal Cannula | Active comparator | Standard treatment Receives: Procedure: Oxygen delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSS Scores
Measured: Study specific
Secondary outcomes (1)
PEWS Score
Measured: Study specific
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2015
- Study completionDec 2017 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Milner, MD, Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662544
- Sponsor's protocol ID
- 1103-041
- Acronym
- HHFNC
- Status last verified
- Jul 2017
- First submitted
- 8 Aug 2012
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Heated Humidified High-flow Nasal Cannula (HHFNC) Versus Standard Nasal Cannula Oxygen Delivery on Respiratory Distress and Length of Stay in Infants With Bronchiolitis and Hypoxia
- ClinicalTrials.gov ID
- NCT01662544
- Acronym / sponsor ID
- HHFNC / 1103-041
- Conditions
- Bronchiolitis, Hypoxia
- Keywords
- Infants, Bronchiolitis, Hypoxia, Emergency Department, Length of Stay, Pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Aug 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.
Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and children. Multiple supportive therapies have been tried in infants with bronchiolitis including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date supportive therapy with oxygen is the only proven therapy to decrease respiratory distress in infants with bronchiolitis, with hypertonic saline showing a borderline statistically significant improvement. This prospective, randomized study will compare CSS and PEWS scores on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen via Humidified High-Flow Nasal Cannula (HHFNC). The results will help determine if infants with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have improved Clinical Severity Score (CSS) and Pediatric Early Warning System (PEWS) scores and ultimately decreased lengths of admissions when compared to patients treated with nasal cannula oxygen therapy with/without bronchodilator therapy.
Hypothesis Heated Humidified High-flow Nasal Cannula Delivery of Oxygen decreases respiratory distress as measured by pediatric CSS and PEWS when compared with routine nasal cannula oxygen delivery in infants with bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HHFNC | Experimental | Procedure: Oxygen deliveryHeated High Flow arm |
| Standard Nasal Cannula | Active comparator | Procedure: Oxygen deliveryStandard treatment |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Are previously healthy infants ages 3 months to 18 months of age
- Have O2 saturations of < 92% on room air while awake
- Have a clinical diagnosis of bronchiolitis
- Have a CSS score showing moderate distress >4
- Have a planned admission to the hospital for either inpatient or observation status
Key exclusion criteria (12 listed)
- Have significant apnea or bradycardia events reported by parent or witnessed in Emergency Department
- Have prior airway disease diagnosis other than URI within the previous two months
- Were previously intubated; previously having had airway bronchoscopy or surgery
- They are ex-preemies, i.e. had an estimated gestational age of <37 weeks at time of birth
- Have a diagnosis of lobar consolidation or round pneumonia by Chest x-ray
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 delivery | Procedure or surgery | HHFNC, Standard Nasal Cannula |
Primary outcome
CSS Scores
Time frame: Study specific
1 secondary outcome
PEWS Score
Time frame: Study specific
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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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.
Donna Milner, MD principal investigator
Children's Hospitals and Clinics of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen delivery in people with Bronchiolitis and Hypoxia, run by Children's Hospitals and Clinics of Minnesota 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 6 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: status not confirmed, as of the sponsor's last update on 19 Jul 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 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?
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?
CSS Scores (time frame: Study specific). 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 Jul 2017.