Funding outcome

Each year in Canada, ~1500 infants are born extremely preterm (<29 weeks gestation). These infants are at high risk of dying, with most requiring resuscitation right at birth. The most important part of this resuscitation is artificial breaths, given by healthcare providers via face masks. This is called Positive Pressure Ventilation (PPV). While lifesaving, if too much air is pumped into the lungs, it can cause lung and brain damage. While, if too little air is pumped in, the infant may be deprived of oxygen, leading to complications, even death. Currently, healthcare providers give PPV manually using pressure-limited devices. It can be hard to give the right amount of PPV. A better way would be for a ventilator to automatically adjust pressures so that the right volume of air is pumped into the lungs. This approach called volume-targeted ventilation (VTV), is commonly used in the neonatal intensive care unit in babies with breathing tubes; however, it has not been tested in babies needing PPV right after birth. Automated, ventilator-directed, volume-targeted mask ventilation (VTV-PPV) can be done using existing ventilators but needs careful testing. As a first step, we propose a single-center feasibility pilot trial. This trial will a) determine if a larger trial can be done using our proposed design, b) test the safety of this approach, and c) obtain data in preparation for a larger trial. Therefore, we aim to recruit 40 infants born at 23 to 28 weeks in 2 years. Before birth, we will randomize each baby to either standard mask ventilation (PPV), or volume-targeted mask ventilation (VTV-PPV). We will follow babies during their hospital stay, track safety and clinical outcomes, and track how successful we are at enrolling a representative sample. This pilot trial will pave the way for a large, international clinical trial. Ultimately, if proven effective, VTV-PPV may improve the survival and long-term outcomes of preterm infants worldwide.