Bronchiolitis Clinical Trial
Official title:
Monitoring OXYgen in Infants Hospitalized With Bronchiolitis: A Best Practices Trial (The MOXY Trial)
In infants hospitalized with bronchiolitis, a common infection in the lungs caused by a
virus, it is uncertain on how to best monitor their oxygen levels. It is common to place a
probe on infants hands or legs to monitor oxygen levels. The probe can be used to monitor
oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours
(intermittent oxygen monitoring). There is reason to believe that placing children with
bronchiolitis on continuous monitoring might result in children staying longer in hospital
than needed. This is a research study that is aiming to provide data to plan a larger
research study to answer the question of whether intermittent oxygen monitoring is better
than continuous oxygen monitoring. This study is part of a larger initiative to determine
the best way to care for children with bronchiolitis, including making sure that children do
not stay in hospital longer than needed.
Parents will be asked to participate in this research study if their child is hospitalized
with bronchiolitis and has been stable for at least 6 hours, meaning that he/she is not
having more trouble breathing or does not require more supplemental oxygen. If they agree
participate, the child will have one of the two oxygen monitoring strategies: intermittent
or continuous monitoring. Each child will have an equal chance of getting one or the other
of these two monitoring strategies.
The study team will review the children's charts to determine the number of tests ordered,
the need for intensive care unit help or admissions, the number of blood tests and chest
x-rays the treating doctors ordered, and the length of hospital stay. Parents will be
contacted about 4-5 days after discharge to ask if there were any unscheduled visits to
doctors or emergency rooms after discharge. The investigators will the parents to fill out a
scale twice a day asking how well their child is feeding. The investigators will also them
to rate their anxiety level once a day.
The information from this study will help plan and support an application for external
funding. The results of a larger study could potentially decrease unnecessary monitoring,
oxygen supplementation, and hospital stay and thereby improve quality of care with large
cost savings. A reduction in length of hospital stay for this common hospital condition
would also reduce the burden of hospitalization to families and reduce the risks associated
with harm in the hospital setting such as infection and medical error.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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