Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia (HHFNC)
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Heated High Flow arm
Procedure: Oxygen delivery
Active Comparator: Standard Nasal Cannula
Procedure: Oxygen delivery
- CSS Scores [ Time Frame: Study specific ]
- PEWS Score [ Time Frame: Study specific ]
- Oxygen needs [ Time Frame: Study specific ]
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 ClinicalTrials.gov identifier (NCT number): NCT01662544
|United States, Minnesota|
|Children's Hospitals and Clinics of Minnesota|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Donna Milner, MD||Children's Hospitals and Clinics of Minnesota|