Overview

This trial is active, not recruiting.

Conditions bronchiolitis, hypoxemia
Treatment heated and humidified oxygen
Sponsor Children's Hospital & Research Center Oakland
Start date January 2014
End date April 2015
Trial size 30 participants
Trial identifier NCT02094664, 2013-066

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Standard therapy
(Active Comparator)
Heated and humified oxygen
heated and humidified oxygen

Primary Outcomes

Measure
Change in Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR) from baseline.
time frame: Study specific

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants up to 24 months old.

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

Additional Information

Official title HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis
Principal investigator Diana Chen, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Children's Hospital & Research Center Oakland.