Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants (VOLT)

This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room.

Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room

Study Overview

• Status: Completed
• Conditions: Neonatal Respiratory Distress
• Intervention / Treatment: Procedure: Volume targeted ventilation; Procedure: Pressure targeted ventilation

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 minute (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Born between 23+0/7 to 28+6/7 weeks' gestation
• Considered suitable for full resuscitation, i.e., no parental request or antenatal decision to forego resuscitation
• Informed parental consent

Exclusion Criteria:

• Major congenital or chromosomal malformation
• Conditions that might have an adverse effect on breathing or ventilation (e.g., high risk for lung hypoplasia, congenital diaphragmatic hernia)
• Congenital heart disease requiring intervention in the neonatal period
• Hydrops requiring intervention in the neonatal period
• Neonatal resuscitation initiated before NICU team arrival
• Infants who are born outside of study center and transported to center after delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volume Targeted Ventilation; Positive pressure ventilation will be provided using a set tidal volume	Procedure: Volume targeted ventilation; Positive pressure ventilation will be provided using a set tidal volume
Active Comparator: Pressure guided Ventilation; Positive pressure ventilation will be provided using a set peak inflation pressure	Procedure: Pressure targeted ventilation; Positive pressure ventilation will be provided using a set peak inflation pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of of eligible participants (=infants requiring PPV) who have the intervention performed correctly without protocol deviation (=cross over to control group when randomized to VTV-group)	Percentage of Participants who have received allocated treatment	Through study completion (total 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with mortality	Infants who died during NICU admission - all-cause in-hospital	up to 6 months of NICU admission
Number of participants with severe brain injury on cranial ultrasound	Severe grade 3 and 4 intraventricular or intraparenchymal hemorrhage according to Papile, periventricular leukomalacia, or ventriculomegaly based on neuroimaging studies (timing and frequency of imaging based on local site practices)	up to 6 months of NICU admission
Number of participants with severe retinopathy of prematurity (stage 3 or higher)	Defined in the International Classification of ROP, and/or ROP treated with laser, cryotherapy, or intraocular injection therap	up to 6 months of NICU admission
Number of participants with bronchopulmonary dysplasia at 36 weeks corrected age	Defined as receiving any supplemental oxygen or any form of respiratory support (including invasive mechanical ventilation, non-invasive ventilation with continuous positive airway pressure, nasal intermittent positive pressure ventilation, or high-flow nasal canula)	At 36 weeks corrected age
Number of participants with Bronchopulmonary dysplasia at 40 weeks corrected age	Defined as receiving any supplemental oxygen or any form of respiratory support (including invasive mechanical ventilation, non-invasive ventilation with continuous positive airway pressure, nasal intermittent positive pressure ventilation, or high-flow nasal canula)	At 40 weeks corrected age
Total duration of mechanical ventilation via an endotracheal tube in days	Count of days in were an endotracheal tube was placed and the infant was mechanical ventilation	Days during NICU admission (up to 6 months)
Number of participants discharge home on oxygen	Infants being discharged home with oxygen	At time of NICU discharge (with 6 moths from birth)
Duration of any respiratory support in days	Defined as invasive mechanical ventilation, non-invasive ventilation with continuous positive airway pressure, nasal intermittent positive pressure ventilation, or non-invasive neural assist ventilation or non-invasive high frequency ventilation, or high-flow nasal cannula) in days	Days during NICU admission (up to 6 months)
Duration of supplemental oxygen in days	Count of days in were the infant received supplemental oxygen	Days during NICU admission (up to 6 months)
Length of hospital stay in days	Defined as number of days from birth to discharge	Number of days from birth to discharge (up to 6 months)
Rate of intubation in the delivery room	Infants who were intubated in the delivery room at birth	within 60min after birth
Rate of chest compression in the delivery room	Infants who received chest compression in the delivery room at birth	within 60min after birth
Rate of pneumothorax	Diagnosed by chest x-ray or lung ultrasound) and interventions (e.g., needle drainage or chest drain)	up to 6 months of NICU admission
Number of participants with necrotizing enterocolitis	Defined as modified Bell's criteria stage 2 or greater	up to 6 months of NICU admission
Duration of positive pressure ventilation at birth in days	Infants who received positive pressure ventilation in the delivery room at birth	within the first 10 min after birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resuscitators subjective workload performing mask ventilation	Es evaluated by Surgery Task Load Index (SURG-TLX)-questionnaire.	within the first 10 min after birth
Resuscitators qualitative feedback on using VTV-PPV in the delivery room	Provided through free text responses	within the first 10 min after birth

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Georg Schmolzer, MD, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): December 17, 2025

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: Pro00115050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The protocol will be published in an open access journal and data can be requested from the principal investigator
• IPD Sharing Time Frame: Protocol will be published within 18 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No