Assistant Professor University of Alberta Faculty of Medicine and Dentistry Edmonton, Alberta, Canada
Background: Assisted ventilation during delayed cord clamping (DCC) may lead to improved cardiorespiratory transition in preterm infants. In the VentFirst randomized controlled trial (RCT), participating sites used a variety of equipment for the intervention, from trays for infant positioning and separate ventilation devices to purpose-built, integrated resuscitation platforms. Objective: We aim to describe equipment and other implementation considerations for this RCT. Design/Methods: This is a secondary description of the VentFirst RCT which recruited from 2016 to March 2023. Infants of consented women delivering at 23+0 to 28+6 weeks gestation were randomized to assisted ventilation from 30 to 120 seconds after birth followed by cord clamping (intervention) or DCC for 30-60 seconds followed by routine resuscitation (control). In this pragmatic design, sites were able to configure teams and equipment to fit their context, so long as protocol was followed. We queried the dataset for infants for whom the intervention was initiated to examine equipment used, duration of DCC, and NICU admission temperatures. Site investigators completed surveys of their experience. Results: For infants for whom the intervention was initiated(n=218), 24% were positioned on purpose-built resuscitation platforms, 17% on other stands, and 58% on a rigid surface on the mothers’ thighs below c-section incision or at the perineum. Median cord clamping time, proportion of infants with >90 seconds DCC, and median NICU admission temperatures were similar between methods, but there were fewer infants with hypothermia < 36.5°C on admission with purpose-built platforms. Heart rates were usually assessed by cord palpation. (Table 1)
Training included simulations, slide presentations and videos. Investigators reflected on equipment, training and implementation challenges, as well as facilitators to success. They estimated that 15-30 minutes was required to prepare for the intervention. Large teams and sporadically occurring interventions were barriers. Obstetrical teams were generally supportive. Other facilitating factors included team buy-in, research team presence, and repeated training. (Table 2)
Conclusion(s): Assisted ventilation during DCC for preterm infants was shown to be feasible across sites. Reasons for the lower hypothermia rate with purpose-built platforms need to be investigated and could be due to non-equipment factors such as training, team experience or other confounders. This intervention should not be performed outside of research studies unless benefits are shown. Human factors should be considered in future clinical trials.
.png)
.png)