Device-Finding Prestudy
In preliminary work, we assessed several suctioning devices. The Zo-Li device generated sustained high negative pressure of 126 mm Hg during the 10-second suctioning interval, which is comparable to the accepted Canada-wide wall suction standard.To assess the benefit of suctioning, we considered a control group receiving no suctioning. To that effect, the original protocol comparing enhanced suction with usual care assumed that usual care would largely consist of no suction or bulb use. However, after enrolling 35 infants (December 26, 2018, to February 7, 2019), we discovered that virtually all parents already used suctioning and that almost no parents continued suctioning beyond 3 days. We, therefore, anticipated that no suctioning would make enrollment difficult and might be considered unethical and, thus, selected standardized minimal suctioning via a bulb as the control group. Because of the strong preference for suctioning found during this initial phase, we anticipated that some parents may use unassigned devices for perceived lack of breathing or feeding improvement, which would also represent additional resource use. We, therefore, incorporated unassigned device use with unscheduled revisits into the revised composite primary outcome and changed the intervention length from 7 days to 72 hours. This change was research ethics board–approved and registered on ClinicalTrials.gov. Please see 