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

This study is currently recruiting participants.
Verified April 2014 by Children's Hospitals and Clinics of Minnesota
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01662544
First received: August 8, 2012
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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 Intervention
Bronchiolitis
Hypoxia
Procedure: Oxygen delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • CSS Scores [ Time Frame: Study specific ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PEWS Score [ Time Frame: Study specific ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Oxygen needs [ Time Frame: Study specific ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HHFNC
Heated High Flow arm
Procedure: Oxygen delivery
Active Comparator: Standard Nasal Cannula
Standard treatment
Procedure: Oxygen delivery

  Eligibility

Ages Eligible for Study:   3 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662544

Contacts
Contact: Heidi Vander Velden 612-813-7892

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Heidi Vander Velden    612-813-7892      
Principal Investigator: Donna Milner, MD         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Donna Milner, MD Children's Hospitals and Clinics of Minnesota
  More Information

No publications provided

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01662544     History of Changes
Other Study ID Numbers: 1103-041
Study First Received: August 8, 2012
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospitals and Clinics of Minnesota:
Infants
Bronchiolitis
Hypoxia
Emergency Department
Length of Stay
Pediatrics

Additional relevant MeSH terms:
Bronchiolitis
Anoxia
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014