Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia



Status:Active, not recruiting
Conditions:Bronchitis, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/20/2017
Start Date:August 2012
End Date:December 2017

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
1
site
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials