Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

Background: Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by
different viruses. It is the most common LRTI in children under 24 months old, accounting
for approximately 90,000 hospitalizations annually and costing over $700 million in children
under 12 months. Health care providers vary in diagnosis and management, however. In 2006
the American Academy of Pediatrics (AAP) released guidelines for bronchiolitis management in
an effort to standardize clinical practice. Part of these guidelines recommends patients
admitted to the hospital receive supplemental oxygen if they are persistently hypoxic, which
is defined as pulse oximeter readings persistently below 90%. However, this recommendation
is based on expert opinion.

Research has previously shown healthy infants routinely experience brief episodes of
decreased oxygen levels while sleeping without significant health effects. Other studies
demonstrate no relationship between short intervals of transient or mildly decreased oxygen
levels and long-term mental or developmental delays. Furthermore, children with
bronchiolitis remain hospitalized longer without any appreciable improvement in the course
or outcome of their illness when continuously monitored for oxygen level.

Widespread pulse oximeter use has increased hospitalization rates over 250%, and close
monitoring increases length of stay for children who otherwise could be discharged home. The
2006 guidelines discourage continuous pulse oximetry monitoring in children not requiring
supplemental oxygen, but health care providers routinely ignore this recommendation. No
studies have assessed the impact of more strictly adhering to the practices recommended by
the AAP.

Research Procedures: This is a randomized control study and is a multi-site collaboration
with University of Missouri Children's Hospital in Columbia, Missouri. Children admitted to
the study sites with bronchiolitis will be batch randomized (i.e. randomized separately at
each site) to undergo either continuous pulse oximetry monitoring throughout the entire
hospitalization or receive intermittent monitoring when not on supplemental oxygen. Patients
will additionally receive all care standard to the management of their illness. Of note, the
proposed intervention is the recommended standard of care for oxygen monitoring compared to
the general practice used at both study sites. Researchers will then review charts after
discharge for length of stay, number of medical interventions performed, diagnostic testing
completed, and treatments provided. Cost of stay for patients in each group will be
estimated and compared as well. Patients will be involved in the study for their entire
admission.

Inclusion Criteria:

- Children less than or equal to 24 months old with a history of term delivery
(gestational age ≥37 weeks) admitted with a presumptive diagnosis of bronchiolitis

- Bronchiolitis will be defined as an episode of wheezing or increased work of
breathing associated with signs of an upper respiratory tract infection experienced
by a patient

- Enrollment within 24 hours of admission

Exclusion Criteria:

- History of severe cardiac or pulmonary illness, including but not limited to
bronchopulmonary dysplasia, chronic lung disease, asthma/reactive airway disease,
congenital heart disease, heart failure, and cardiothoracic surgery

- History of home albuterol use for asthma or reactive airway disease

- History of use of bronchodilator with successful patient response to the medication

- Use of corticosteroids within the past two weeks up to day of admission

- Use of antibiotics after admission for suspected pneumonia or similar pulmonary
disease

- History of premature birth (<37 weeks gestation)

- History of receiving palivizumab (anti-RSV antibody)

- Diagnosis of chronic immune deficiency, hematologic dyscrasia, or cancer

- Chronic treatment with immunosuppressants

- Parents/guardians unable to give informed consent in English

- Need for PICU transfer at any point during illness

- Transfer from an outside institution where patient was hospitalized for ≥12 hours

- Previous enrollment in this study

- Pediatric attending refuses to comply with study protocol