Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia (HHFNC)
Primary Purpose
Bronchiolitis, Hypoxia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen delivery
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Infants, Bronchiolitis, Hypoxia, Emergency Department, Length of Stay, Pediatrics
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Children's Hospitals and Clinics of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HHFNC
Standard Nasal Cannula
Arm Description
Heated High Flow arm
Standard treatment
Outcomes
Primary Outcome Measures
CSS Scores
Secondary Outcome Measures
PEWS Score
Full Information
NCT ID
NCT01662544
First Posted
August 8, 2012
Last Updated
July 18, 2017
Sponsor
Children's Hospitals and Clinics of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01662544
Brief Title
Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia
Acronym
HHFNC
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Hypoxia
Keywords
Infants, Bronchiolitis, Hypoxia, Emergency Department, Length of Stay, Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HHFNC
Arm Type
Experimental
Arm Description
Heated High Flow arm
Arm Title
Standard Nasal Cannula
Arm Type
Active Comparator
Arm Description
Standard treatment
Intervention Type
Procedure
Intervention Name(s)
Oxygen delivery
Primary Outcome Measure Information:
Title
CSS Scores
Time Frame
Study specific
Secondary Outcome Measure Information:
Title
PEWS Score
Time Frame
Study specific
Other Pre-specified Outcome Measures:
Title
Oxygen needs
Time Frame
Study specific
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Milner, MD
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia
We'll reach out to this number within 24 hrs