Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bronchiolitis, Hypoxia

Intervention / Treatment
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* Procedure: Oxygen delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HHFNC<br>Heated High Flow arm | Procedure: Oxygen delivery<br> <br> |
| Active Comparator: Standard Nasal Cannula<br>Standard treatment | Procedure: Oxygen delivery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSS Scores |  | Study specific | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEWS Score |  | Study specific | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants, Bronchiolitis, Hypoxia, Emergency Department, Length of Stay, Pediatrics