Suctioning of NOse Therapy in Bronchiolitis - a Randomized Clinical Trial

Research Questions:

Primary:

In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with acute bronchiolitis,1 is there a difference in the probability of "treatment failure" by 72 hours post discharge from the index ED visit in those receiving nasal suctioning via Zo-Li device prior to feeds compared to infants who receive nasal suctioning via bulb? Treatment failure is defined as 1) any bronchiolitis-related healthcare visit, except visits that have occurred only due to ED-recommendation at time of ED discharge or 2) the use of additional (non-study assigned) suctioning devices (see Outcome Measures section) within approximately 72 hours post discharge at the index ED visit.

Hypothesis:

We hypothesize that the infants who undergo scheduled nasal suctioning via ZoLi device will experience a lower treatment failure probability by approximately 72 hours post discharge from index ED visit compared to those managed by suction via a bulb.

Secondary:

1. In these infants, is there a difference in the mean number of medical visits for bronchiolitis (defined as #1 under primary outcome above) within 72 hours of ED discharge?
2. In these infants, is there a difference in the mean number of unscheduled medical visits for bronchiolitis within 72 hours of ED discharge?
3. In these infants, is there a difference in the mean number of ED visits for bronchiolitis within 72 hours of ED discharge?
4. In these infants, is there a difference in the probability of a parent reporting normal/near normal feeds on approximately 72 hours discharge?
5. In these infants, is there a difference in the probability of a parent reporting normal/near normal sleeping on approximately 72 hours post ED discharge?
6. For the parent, is there a difference in the probability of a parent reporting their own normal/near normal sleeping on approximately 72 hours post ED discharge?
7. In these infants, is there a difference in the probability of parents reporting at 72 hours post ED discharge as being "very satisfied" or "satisfied" with their ability to care for their child during the study period?

The sample size calculation is based on the assessment of the between-group difference in probability of treatment failure. The estimated total re-visit probability in bronchiolitis based on a recently published study was approximately 35% within 72 hours of ED discharge.49 In our pilot we have found the same rate of treatment failure. This is a superiority study in which the adoption of nasal suctioning will be recommended for future practice if the observed proportion of the primary outcome in this group is significantly lower than in the controls. With 162 patients per arm (324 in total) a two-sided test with a type I error of 0.05 will have 80% power to achieve statistical significance if suctioning reduces the probability of treatment failure from 40% to 25% (i.e. absolute reduction of 15%). This estimate is based on clinically relevant differences agreed upon by study investigators and it also represents an NNT of 7. In the Cochrane review of asthma therapies an NNT of a comparable magnitude led to a change in national practice recommendations.51 Since bronchiolitis and related medical visits are highly prevalent,20 this target difference would also have an important economic impact. Based on our previous bronchiolitis trials, the anticipated refusal rate may be 20%. Given the study design and our past experience, the study non-completion rate and loss to follow-up can safely be assumed to be no higher than 5% each. Therefore, to have complete data on 324 patients we plan to randomize 360 (i.e. 324/ (1 - 0.05) *(1 - 0.05) and to approach 450 (i.e. 360/ (1 - 0.20).