Neonatal Respiratory DistressVOLTNCT05144724
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
A study testing Volume targeted ventilation and Pressure targeted ventilation in people with Neonatal Respiratory Distress, run by University of Alberta at 1 site in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 0 minutes to 1 minute
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- Volume targeted ventilation and Pressure targeted ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Neonatal Respiratory Distress
- Being tested
- Volume targeted ventilation, Pressure targeted ventilation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume targeted ventilationProcedure or surgery
Positive pressure ventilation will be provided using a set tidal volume
Pressure targeted ventilationProcedure or surgery
Positive pressure ventilation will be provided using a set peak inflation pressure
| Study group | Role | What they receive |
|---|---|---|
| Volume Targeted Ventilation | Experimental | Positive pressure ventilation will be provided using a set tidal volume Receives: Procedure: Volume targeted ventilation |
| Pressure guided Ventilation | Active comparator | Positive pressure ventilation will be provided using a set peak inflation pressure Receives: Procedure: Pressure targeted ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion (total 18 months)
Secondary outcomes (15)
Number of participants with mortality
Infants who died during NICU admission - all-cause in-hospital
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Days during NICU admission (up to 6 months)
Number of participants discharge home on oxygen
Infants being discharged home with oxygen
Measured: 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
Measured: Days during NICU admission (up to 6 months)
Duration of supplemental oxygen in days
Count of days in were the infant received supplemental oxygen
Measured: Days during NICU admission (up to 6 months)
Length of hospital stay in days
Defined as number of days from birth to discharge
Measured: 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
Measured: within 60min after birth
Rate of chest compression in the delivery room
Infants who received chest compression in the delivery room at birth
Measured: within 60min after birth
Rate of pneumothorax
Diagnosed by chest x-ray or lung ultrasound) and interventions (e.g., needle drainage or chest drain)
Measured: up to 6 months of NICU admission
Number of participants with necrotizing enterocolitis
Defined as modified Bell's criteria stage 2 or greater
Measured: 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
Measured: within the first 10 min after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Oct 2024
- Primary completion30 Oct 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Schmölzer, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144724
- Sponsor's protocol ID
- Pro00115050
- Acronym
- VOLT
- Status last verified
- Jan 2026
- First submitted
- 21 Oct 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol will be published in an open access journal and data can be requested from the principal investigator
Publications
Law BHY, Yaskina M, Davis PG, Polglase G, Dunn M, Mukerji A, Schmolzer GM. Study protocol for the volume targeted mask ventilation versus pressure ventilation in preterm infants-the VOLT-trial. Front Pediatr. 2026 Jan 6;13:1743460. doi: 10.3389/fped.2025.1743460. eCollection 2025.
PubMed 41567425Bharadwaj U, Kainth D, Sankar J. Refining Ventilation During Neonatal Resuscitation Using Ventilator: Time for a Well-Designed Clinical Study! Indian J Pediatr. 2024 Oct;91(10):997-998. doi: 10.1007/s12098-024-05154-6. Epub 2024 May 10. No abstract available.
PubMed 38727883
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
- ClinicalTrials.gov ID
- NCT05144724
- Acronym / sponsor ID
- VOLT / Pro00115050
- Conditions
- Neonatal Respiratory Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volume Targeted Ventilation | Experimental | Procedure: Volume targeted ventilationPositive pressure ventilation will be provided using a set tidal volume |
| Pressure guided Ventilation | Active comparator | Procedure: Pressure targeted ventilationPositive pressure ventilation will be provided using a set peak inflation pressure |
Who may qualify
- Ages
- 0 minutes to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume targeted ventilationPositive pressure ventilation will be provided using a set tidal volume | Procedure or surgery | Volume Targeted Ventilation |
| Pressure targeted ventilationPositive pressure ventilation will be provided using a set peak inflation pressure | Procedure or surgery | Pressure guided Ventilation |
Primary outcome
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
15 secondary outcomes
Number of participants with mortality
Time frame: 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
Number of participants with severe retinopathy of prematurity (stage 3 or higher)
Time frame: 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
Number of participants with Bronchopulmonary dysplasia at 40 weeks corrected age
Time frame: 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)
Number of participants discharge home on oxygen
Time frame: 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)
Duration of supplemental oxygen in days
Time frame: 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)
Rate of intubation in the delivery room
Time frame: within 60min after birth
Rate of chest compression in the delivery room
Time frame: within 60min after birth
Rate of pneumothorax
Time frame: up to 6 months of NICU admission
Number of participants with necrotizing enterocolitis
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Derived from this study: PubMed 41567425Law BHY, Yaskina M, Davis PG, Polglase G, Dunn M, Mukerji A, Schmolzer GM. Study protocol for the volume targeted mask ventilation versus pressure ventilation in preterm infants-the VOLT-trial. Front Pediatr. 2026 Jan 6;13:1743460. doi: 10.3389/fped.2025.1743460. eCollection 2025.
- Derived from this study: PubMed 38727883Bharadwaj U, Kainth D, Sankar J. Refining Ventilation During Neonatal Resuscitation Using Ventilator: Time for a Well-Designed Clinical Study! Indian J Pediatr. 2024 Oct;91(10):997-998. doi: 10.1007/s12098-024-05154-6. Epub 2024 May 10. No abstract available.
- Individual participant dataSharing planned: Yes. The protocol will be published in an open access journal and data can be requested from the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Schmölzer, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume targeted ventilation and Pressure targeted ventilation in people with Neonatal Respiratory Distress, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.