Comparison of High Flow Nasal Cannula Therapy to Nasal Oxygen as a Treatment for Obstructive Sleep Apnea in Infants

The current standard of care for treating OSA in infants less than 6 months and frequently up
to 12 months of age is with a continuous flow of oxygen by nasal cannula. This is generally
referred to as nasal continuous positive airway pressure or NCPAP. A nasal cannula is used
with oxygen at low flows of between 1/4 to 1 liter per minute (l/m) to deliver supplemental
oxygen to reduce oxygen desaturations associated with apneic episodes and to provide a
positive pressure flow to maintain an open airway.

High Flow Nasal Cannula (HFNC) therapy is a non-invasive treatment providing respiratory
support. In this study, HFNC is designed to administer a heated and humidified mixture of air
at a flow higher than the patient's inspiratory flow. There is currently no single, simple
definition of high flow. In infants, it usually refers to a flow of >2 l/min and in children
it is considered >6 l/min. High flow presents several advantages over conventional 'low-flow'
oxygen therapy in terms of humidification, oxygenation, gas exchange, and breathing pattern.
Several studies have shown that a flow higher than the patient's inspiratory flow provides
better oxygen delivery than low-flow oxygen therapy or high-concentration oxygenation mask.
This observation has been explained as the effect of a high flow on the oropharyngeal dead
space, washing out oxygen depleted gas and reducing carbon dioxide (CO2) rebreathing. The
extrathoracic dead space is proportionally two to three times greater in children than in
adults. It may measure up to 3 mL/kg in newborns and becomes similar to the adult volume only
after 6 years of age (0.8 mL/kg). Consequently, the younger a child is, the greater the
effect of a high flow on oxygenation and CO2 clearance.

This pilot study is to compare standard of care low flow nasal oxygen to the effectiveness of
HFNC therapy in infants aged 12 months and younger to treat OSA. The study intervention will
occur for approximately 3 to 4 hours immediately prior to a scheduled clinical PSG. Subjects
will be prepared for standard clinical PSG and after asleep, the intervention will be
titration of room air at different pressure flows delivered by a HFNC system. At the end of
the research portion of the PSG, the clinical PSG will begin with the standard of care
treatment, the nasal oxygen titration for OSA. The results of the clinical PSG will serve as
control comparison for the research intervention.

Inclusion Criteria:

- Infants ≤ 12 months

- Diagnosis of OSA from previous PSG

Exclusion Criteria:

- Infants who on previous PSG had central apneas > 50% of the AHI