Recruitment Completed for the VOLT-Trial

We are pleased to announce that recruitment has been successfully completed for the VOLT-Trial (Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants – a randomized controlled trial).

About the Study

This pilot randomized controlled trial enrolled 50 preterm infants (23–28 weeks’ gestation) who required respiratory support at birth. Infants were randomized to receive either pressure-guided mask ventilation or volume-targeted mask ventilation in the delivery room.

The primary objective of the VOLT-Trial is to evaluate the feasibility of using Volume Targeted Ventilation (VTV) at birth. We hypothesize that VTV, compared with traditional pressure-guided ventilation, may improve early clinical outcomes for extremely preterm infants.

Key Features of the Trial

• Design: Two-arm parallel pilot RCT

• Sample Size: 50 infants (25 control / 25 intervention)

• Primary Endpoint: Proportion of infants receiving allocated treatment

• Secondary Outcomes: Mortality prior to discharge, delivery room interventions, admission temperature, need for mechanical ventilation, use of inotropes, infection/sepsis, NEC, pneumothorax, BPD, ROP, and brain injury on neuroimaging

• Safety: Continuous monitoring of adverse events

Next Steps

With recruitment now complete, we are moving into the data analysis phase. The final results will provide valuable insights into the potential of volume-targeted ventilation in the delivery room and inform the design of future large-scale clinical trials.

We extend our sincere thanks to the participating families, research teams, and clinical staff across the Canadian study sites who made this important milestone possible.