COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia (HHFNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01662544
Recruitment Status : Unknown
Verified July 2017 by Children's Hospitals and Clinics of Minnesota.
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2012
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Hypoxia Procedure: Oxygen delivery Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2012
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: HHFNC
Heated High Flow arm
Procedure: Oxygen delivery
Active Comparator: Standard Nasal Cannula
Standard treatment
Procedure: Oxygen delivery

Primary Outcome Measures :
  1. CSS Scores [ Time Frame: Study specific ]

Secondary Outcome Measures :
  1. PEWS Score [ Time Frame: Study specific ]

Other Outcome Measures:
  1. Oxygen needs [ Time Frame: Study specific ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   3 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Are previously healthy infants ages 3 months to 18 months of age
  2. Have O2 saturations of < 92% on room air while awake
  3. Have a clinical diagnosis of bronchiolitis
  4. Have a CSS score showing moderate distress >4
  5. Have a planned admission to the hospital for either inpatient or observation status
  6. Have parental consent to enroll in study

Exclusion Criteria:

  1. Have significant apnea or bradycardia events reported by parent or witnessed in Emergency Department
  2. Have prior airway disease diagnosis other than URI within the previous two months
  3. Were previously intubated; previously having had airway bronchoscopy or surgery
  4. They are ex-preemies, i.e. had an estimated gestational age of <37 weeks at time of birth
  5. Have a diagnosis of lobar consolidation or round pneumonia by Chest x-ray
  6. Have pleural disease by chest x-ray
  7. Have history of cardiac disease, renal disease, hematologic disease such as sickle cell disease or leukemia, congenital hemoglobinopathies or Congenital Adrenal Hyperplasia
  8. Have undergone prior radiation or chemotherapy
  9. Have functional or anatomical bowel obstruction as demonstrated by persistent vomiting or tensely distended abdomen
  10. Have history of Choanal atresia or cleft palate
  11. Have history of neuromuscular disorder, e.g., Spinal muscular atrophy, muscular dystrophies, cerebral palsy or hypotonia
  12. Have impending respiratory failure as demonstrated by blood gas with pCO2 of greater than 60 or apnea spells lasting greater than 30 seconds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01662544

Layout table for location information
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Layout table for investigator information
Principal Investigator: Donna Milner, MD Children's Hospitals and Clinics of Minnesota
Layout table for additonal information
Responsible Party: Children's Hospitals and Clinics of Minnesota Identifier: NCT01662544    
Other Study ID Numbers: 1103-041
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Keywords provided by Children's Hospitals and Clinics of Minnesota:
Emergency Department
Length of Stay
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections