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Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Children's Hospital & Research Center Oakland.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Diana Chen, Children's Hospital & Research Center Oakland Identifier:
First received: March 18, 2014
Last updated: March 23, 2015
Last verified: March 2015

The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen in children with bronchiolitis.

The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of breathing, and 3) decrease length of hospital stay.

Condition Intervention
Device: Heated and humidified oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis

Resource links provided by NLM:

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Change in Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR) from baseline. [ Time Frame: Study specific ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Subjects will be followed for the duration of hospital stay ]
  • Duration of supplemental oxygen requirement [ Time Frame: Subjects will be followed for the duration of oxygen requirement ]

Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard oxygen via nasal cannula
Standard therapy
Active Comparator: Heated and humidified oxygen
Heated and humified oxygen
Device: Heated and humidified oxygen

Detailed Description:

Bronchiolitis is the leading cause of acute respiratory illness and hospitalization in infants and young children. The mainstay of treatment is supportive care, which includes frequent nasal suctioning, intravenous fluid hydration, and supplemental oxygen for hypoxemia.

The airways normally heat and humidify inspired ambient air to core temperature amd 100% relative humidity at the carina. This environment, at core temperature, allows for optimal mucociliary clearance. Supplemental oxygen delivered via wall source is cold and dry, and does not reach core temperature and 100% humidity until some point distal to the carina, past the main bronchi. This presses on the lower respiratory tract to assist in heat and moisture exchange and thus decrease ciliary function. This, in combination with bronchiolitis, can impair mucociliary clearance.

Specific aim 1: Determine the effect of heated and humidified oxygen therapy on clinical improvement in children with bronchiolitis, based on Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR).

Specific aim 2: Determine the effect of heated and humidified oxygen therapy on length of hospital stay and duration of supplemental oxygen requirement in children with bronchiolitis.


Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages ≤24 months of age
  • Physician diagnosed bronchiolitis
  • Admitted to pediatric floor
  • Supplemental oxygen requirement, <4 L/min, for hypoxemia, oxygen saturation <92% in room air

Exclusion Criteria:

  • Prematurity, born <37 weeks gestational age
  • Admitted to pediatric intensive care unit for medical indication
  • Requirement of heated, humidified high flow system
  • Chronic lung disease (such as bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, tracheostomy status, baseline oxygen requirement)
  • Neuromuscular disorders
  • Chromosomal defects
  • Metabolic disorders
  • Immunodeficiency
  • Unrepaired cardiac abnormalities
  Contacts and Locations
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Please refer to this study by its identifier: NCT02094664

United States, California
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Principal Investigator: Diana Chen, M.D. Children's Hospital & Research Center Oakland
  More Information

Responsible Party: Diana Chen, Pediatric Pulmonary Fellow, Children's Hospital & Research Center Oakland Identifier: NCT02094664     History of Changes
Other Study ID Numbers: 2013-066
Study First Received: March 18, 2014
Last Updated: March 23, 2015

Keywords provided by Children's Hospital & Research Center Oakland:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms processed this record on April 27, 2017