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

January 12, 2026 updated by: University of Alberta

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: Through study completion (total 18 months)
Percentage of Participants who have received allocated treatment
Through study completion (total 18 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with mortality
Time Frame: up to 6 months of NICU admission
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
Time Frame: up to 6 months of NICU admission
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)
Time Frame: up to 6 months of NICU admission
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
Time Frame: 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
Time Frame: 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
Time Frame: Days during NICU admission (up to 6 months)
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
Time Frame: At time of NICU discharge (with 6 moths from birth)
Infants being discharged home with oxygen
At time of NICU discharge (with 6 moths from birth)
Duration of any respiratory support in days
Time Frame: Days during NICU admission (up to 6 months)
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
Time Frame: Days during NICU admission (up to 6 months)
Count of days in were the infant received supplemental oxygen
Days during NICU admission (up to 6 months)
Length of hospital stay in days
Time Frame: Number of days from birth to discharge (up to 6 months)
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
Time Frame: within 60min after birth
Infants who were intubated in the delivery room at birth
within 60min after birth
Rate of chest compression in the delivery room
Time Frame: within 60min after birth
Infants who received chest compression in the delivery room at birth
within 60min after birth
Rate of pneumothorax
Time Frame: up to 6 months of NICU admission
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
Time Frame: up to 6 months of NICU admission
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
Time Frame: within the first 10 min after birth
Infants who received positive pressure ventilation in the delivery room at birth
within the first 10 min after birth

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resuscitators subjective workload performing mask ventilation
Time Frame: within the first 10 min after birth
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
Time Frame: within the first 10 min after birth
Provided through free text responses
within the first 10 min after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Georg Schmolzer, MD, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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