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High-flow oxygen therapy was associated with improved outcomes among hospitalized infants with bronchiolitis treated outside intensive care units (ICUs) in a multicenter, randomized trial.

Compared with infants treated with standard oxygen therapy, roughly half as many infants in the high-flow oxygen group required escalation of care (12% versus 23%), and there was no significant difference between the two groups in the incidence of adverse events.

Bronchiolitis is the most common reason for hospital admission among infants worldwide, and in the U.S. it is responsible for

High-flow oxygen therapy is increasingly being used outside the ICU to provide respiratory support for infants, children, and adults with respiratory diseases.

The new study, published online in the , is among the first to examine the treatment's safety and efficacy outside the ICU in infants with bronchiolitis, said the study's senior researcher, Andreas Schibler, MD, of the University of Queensland in South Brisbane, Australia.

Schibler noted that the findings were similar to those of a

In that study, the treatment failure rate was more than twice as high among children receiving standard therapy than among children treated with high-flow oxygen (33% versus 14%).

"These studies demonstrate that this treatment is easy to use and safe outside the intensive care unit," Schibler told MedPage Today. "We believe it is a game changer."

The study by Schibler et al included 1,472 infants younger than 12 months of age who required supplemental oxygen therapy during hospitalization for bronchiolitis, randomized to receive standard therapy or high-flow oxygen.

Infants in the standard-therapy group were allowed to cross over to receive rescue high-flow oxygen therapy if their condition met the criteria for treatment failure.

The primary outcome was escalation of care due to treatment failure (defined as meeting three or more of the four clinical criteria: persistent tachycardia, tachypnea, hypoxemia, and medical review triggered by a hospital early-warning tool).

Of the 739 infants initially randomized to the high-flow group, 87 (12%) required escalation of care, compared with 167 of the 733 infants randomized to the standard-therapy group (risk difference -11 percentage points, 95% CI -15 to -7; P<0.001).

No significant differences were observed in the duration of hospital stay or the duration of oxygen therapy.

In each group, one case of pneumothorax (<1% of infants) occurred. Among the 167 infants in the standard-therapy group for whom treatment failed, 102 (61%) had a response to high-flow rescue therapy.

"The rescue use of high-flow oxygen therapy reflected a real-world scenario, because high-flow therapy was used as standard practice in Australia and New Zealand at the time of our trial," the researchers wrote. "Denying clinicians the option to use rescue high-flow therapy in infants in the standard-oxygen group would have prevented us from performing the trial."

Schibler noted that the group is currently conducting a study of high-flow oxygen therapy in children older than 1 year being treated outside the ICU. High-flow oxygen therapy in this setting could have the biggest impact in areas with fewer health resources, he said: "Mortality due to bronchiolitis is a big issue in these under-resourced countries. This intervention is safe, easy, and relatively cheap."

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