Study Protocol SpotlightThe VOLT Trial: Volume-Targeted Mask Ventilation versus Pressure Ventilation in Preterm Infants

georgschmoelzer
3 days ago
3 min read

Providing effective and gentle respiratory support in the first minutes after birth is one of the most critical—and challenging—tasks in neonatal care. The VOLT trial (Volume-Targeted mask ventilation versus pressure ventilation in preterm infants) was designed to address a fundamental gap in delivery room practice: how to reliably deliver safe tidal volumes during positive pressure ventilation (PPV) immediately after birth.

Why does this matter?

When preterm infants fail to breathe spontaneously at birth, PPV via a face mask is the cornerstone of resuscitation. In most delivery rooms, PPV is provided using a T-piece resuscitator with a fixed peak inflation pressure (PIP), without measuring the actual tidal volume (VT) delivered to the lungs. Clinicians judge adequacy by chest rise and heart rate—yet multiple studies show that chest wall movement is difficult to assess reliably.

This matters because preterm lungs are exquisitely vulnerable. Delivery-room studies have shown VT delivery ranging from 0 to 31 mL/kg, far exceeding what is considered lung-protective. Experimental and clinical evidence consistently links high VT (>8 mL/kg) to lung injury and brain injury, including intraventricular hemorrhage (IVH).

From NICU principles to the delivery room

In the NICU, volume-targeted ventilation (VTV) is standard of care. Ventilators automatically adjust pressure to deliver a set VT, and large meta-analyses show that VTV reduces:

Pneumothorax
Hypocarbia
Death or bronchopulmonary dysplasia
Severe brain injury (PVL or grade 3–4 IVH)

Despite this strong evidence, VTV has not been systematically applied in the delivery room during mask ventilation—precisely when the lungs and brain may be most vulnerable.

The key question

Can volume-targeted mask ventilation be used safely and feasibly in the delivery room, and does it have the potential to improve outcomes for extremely preterm infants?

The VOLT trial at a glance

The VOLT trial is a single-center randomized controlled feasibility trial conducted at the Royal Alexandra Hospital in Edmonton, Canada.

PopulationPreterm infants born between 23+0 and 28+6 weeks’ gestation who require PPV at birth.

Intervention

VTV-PPV group: Mask ventilation using a mechanical ventilator with volume guarantee (target VT 5–6 mL/kg).

Comparator

PPV group: Standard mask ventilation using a T-piece resuscitator with pressure-limited ventilation.

Timeline

Intervention applied during the first 10 minutes after birth.

Primary objective

To determine the feasibility and safety of VTV-PPV in the delivery room, defined as the proportion of eligible infants who receive the assigned intervention without protocol deviation.

Secondary objectives

The trial will also explore whether VTV-PPV may:

Reduce severe brain injury, bronchopulmonary dysplasia, and severe retinopathy of prematurity
Reduce intubation rates in the delivery room by facilitating transition to CPAP
Lower rates of pneumothorax and other respiratory complications
Influence clinician workload and user experience during resuscitation

Importantly, the study also captures qualitative feedback from healthcare providers, recognizing that feasibility is not only technical, but human.

Why this study is important

The VOLT trial represents a logical next step in neonatal resuscitation research: extending lung-protective strategies from the NICU into the delivery room. If feasible, this approach offers continuity of care from the very first breath and may reduce early lung and brain injury in the most vulnerable infants.

This feasibility trial will inform the design of a future large, multicenter international trial powered to assess clinical outcomes.