Neonatal ResuscitationMVPNCT06849596
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
A study testing Ventilator derived positive pressure ventilation - V-PPV and T-piece resuscitator (TPR) in people with Neonatal Resuscitation and Apnea Neonatal, run by Michelle Baczynski at 11 sites in 3 countries.
Trial summary
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. Read more about this study
- Who is it for?
- Ages 25 to 29 weeks
- Conditions the study is for
- Neonatal Resuscitation, Apnea Neonatal
- What is being tested?
- Ventilator derived positive pressure ventilation - V-PPV and T-piece resuscitator (TPR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 1 Dec 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 29 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GA 25+0 to 28+6 weeks using the best available obstetrical estimate
- Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care
- Received PPV as determined by the resuscitation team during the first 10 minutes of birth
Who cannot join
- Outborn birth status
- Resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward)
- Known major congenital or chromosomal anomaly
- Established spontaneous respiration without receipt of PPV
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
Canada9 sites, 8 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
Amuchou Soraisham, MD, 403-944-4638, amuchou.soraisham@albertahealthservices.ca
Amuchou Soraisham, MD
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta
Georg Schmölzer, MD, 780-735-4647, georg.schmoelzer@me.com
Georg Schmölzer, MD
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario
Amit Mukerji, MD, 905-521-2100 ext. 76486, mukerji@mcmaster.ca
Amit Mukerji, MD
- Withdrawn
Children's Hospital at London Health Sciences Centre
London, Ontario
- Recruiting
Montreal Children's Hospital
Montral, Quebec
Marc Beltempo, MD, 514-412-4230 ext. 23032, marc.beltempo@mcgill.ca
Marc Beltempo, MD
- Recruiting
CHU Sainte Justine
Montreal, Quebec
Ahmed Moussa, MD, 514-345-4931 ext. 3109, ahmed.moussa.med@ssss.gouv.qc.ca
Ahmed Moussa, MD
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Dany Weisz, MD, 416-480-6100, dany.weisz@sunnybrook.ca
Maher Shahroor, MD, 416-480-6100, maher.shahroor@sunnybrook.ca
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Michelle Baczynski, MSc, 4165864800 ext. 173037, michelle.baczynski@sinaihealth.ca
Michelle Baczynski, MSc
- Not yet recruiting
BC Children's and Women's Hospital
Vancouver, British Columbia
Jonathan Wong, MD, 604-875-200 ext. 7344, jonathan.wong@cw.bc.ca
Jonathan Wong, MD
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Guerin Children's
Los Angeles, California, 90505
Manoj Biniwale, MD, 310-423-4434, biniwale@usc.edu
Manoj Biniwale, MD
Denmark1 site, 1 recruiting
- Not yet recruiting
Rigshospitalet Coppenhagen
Copenhagen
Christian Heiring, MD, christian.heiring@regionh.dk
Christian Heiring, MD
About this study
Official title: A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.
- Conditions
- Neonatal Resuscitation, Apnea Neonatal
- Being tested
- Ventilator derived positive pressure ventilation - V-PPV, T-piece resuscitator (TPR)
- Keywords
- Premature Infant, Preterm Neonates, Oxygen, Lung Injury, Respiration, Artificial, Resuscitation, Ventilator, Mechanical
- Medical subject headings
- Premature Birth, Lung Injury, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator derived positive pressure ventilation - V-PPVDevice
The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. Ventilator delivered positive pressure ventilation (V-PPV) using a nasal interface will be delivered to the infant in the resuscitation room.
T-piece resuscitator (TPR)Device
The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. PPV will be provided with a T-piece resuscitator (Neopuff, Fisher \& Paykel Healthcare) connected to an appropriately sized face-mask.
| Study group | Role | What they receive |
|---|---|---|
| Control group (T-Piece Resuscitator) | Active comparator | Positive pressure ventilation during the first 10 minutes after birth will be provided with a T-Piece Resuscitator (TPR; Neopuff, Fisher \& Paykel Healthcare) connected to an appropriately sized face-mask, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites. Receives: Device: T-piece resuscitator (TPR) |
| Intervention under investigation (Ventilator delivered PPV) | Experimental | Positive pressure ventilation (PPV) during the first 10 minutes after birth will be provided using a neonatal ventilator set up in noninvasive positive pressure ventilation (NIPPV) mode, connected to an appropriately sized nasal mask or prongs and a dual limb neonatal ventilator circuit, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, respiratory rate and inspiratory time and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites. Receives: Device: Ventilator derived positive pressure ventilation - V-PPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of pre-discharge mortality
Death in NICU
Measured: From enrollment through study completion (up to 50 weeks postmenstrual age)
Major neuro-injury
Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia.
Measured: From enrollment through study completion (up to 50 weeks postmenstrual age)
Moderate-severe BPD
Defined as 2 L/min nasal cannula or other forms of non-invasive ventilation support or invasive mechanical ventilation.
Measured: At 36 weeks' postmenstrual age.
Secondary outcomes (5)
Components of the primary outcome
Pre-discharge mortality, major neuro-injury or moderate-severe BPD
Measured: From enrollment through study completion (up to 50 weeks postmenstrual age)
Frequency of receipt of advanced cardiopulmonary resuscitation measures
Chest compressions or epinephrine administration for the purpose of resuscitation.
Measured: From enrollment to 1 hour post intervention.
Duration of invasive mechanical ventilation during NICU admission
Total number of days on invasive mechanical ventilation
Measured: From enrollment through study completion (up to 50 weeks postmenstrual age)
Discharge on home oxygen
Discharge from the NICU requiring oxygen support at home
Measured: From enrollment through study completion (up to 50 weeks postmenstrual age)
Other relevant key prematurity related adverse outcome
Necrotizing enterocolitis ≥ stage 2a, retinopathy of prematurity needing treatment.
Measured: From enrollment through study completion (up to 50 weeks postmenstrual age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Dec 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- This study will be a cluster-crossover, unmasked randomized control trial (RCT) comparing the clinical effectiveness of two existing methods for providing PPV to preterm neonates born 25+0 to 28+6 weeks gestational age during initial resuscitation after birth.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michelle Baczynski
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Alexandra Hospital, Foothills Medical Centre, McMaster Children's Hospital, St. Justine's Hospital, Cedars-Sinai Medical Center, Montreal Children's Hospital of the MUHC, Sunnybrook Health Sciences Centre, BC Women's Hospital & Health Centre, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Michelle Baczynski, Mount Sinai Hospital, Canada
- Investigators
- Michelle Baczynski, MSc, RRT, Principal investigator, MOUNT SINAI HOSPITALAmish Jain, MBBS, MRCPCH, PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849596
- Sponsor's protocol ID
- CTO 5018
- Acronym
- MVP
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial
- ClinicalTrials.gov ID
- NCT06849596
- Acronym / sponsor ID
- MVP / CTO 5018
- Conditions
- Neonatal Resuscitation, Apnea Neonatal
- Keywords
- Premature Infant, Preterm Neonates, Oxygen, Lung Injury, Respiration, Artificial, Resuscitation, Ventilator, Mechanical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Michelle BaczynskiUniversity, hospital or other
- Collaborators
- Royal Alexandra Hospital, Foothills Medical Centre, McMaster Children's Hospital, St. Justine's Hospital, Cedars-Sinai Medical Center, Montreal Children's Hospital of the MUHC, Sunnybrook Health Sciences Centre, BC Women's Hospital & Health Centre, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Feb 2025 (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.
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a cluster-crossover, unmasked randomized control trial (RCT) comparing the clinical effectiveness of two existing methods for providing PPV to preterm neonates born 25+0 to 28+6 weeks gestational age during initial resuscitation after birth.
| Arm | Type | Receives |
|---|---|---|
| Control group (T-Piece Resuscitator) | Active comparator | Device: T-piece resuscitator (TPR)Positive pressure ventilation during the first 10 minutes after birth will be provided with a T-Piece Resuscitator (TPR; Neopuff, Fisher \& Paykel Healthcare) connected to an appropriately sized face-mask, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites. |
| Intervention under investigation (Ventilator delivered PPV) | Experimental | Device: Ventilator derived positive pressure ventilation - V-PPVPositive pressure ventilation (PPV) during the first 10 minutes after birth will be provided using a neonatal ventilator set up in noninvasive positive pressure ventilation (NIPPV) mode, connected to an appropriately sized nasal mask or prongs and a dual limb neonatal ventilator circuit, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, respiratory rate and inspiratory time and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites. |
Who may qualify
- Ages
- 25 to 29 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- GA 25+0 to 28+6 weeks using the best available obstetrical estimate
- Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care
- Received PPV as determined by the resuscitation team during the first 10 minutes of birth
Key exclusion criteria (4 listed)
- Outborn birth status
- Resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward)
- Known major congenital or chromosomal anomaly
- Established spontaneous respiration without receipt of PPV
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 |
|---|---|---|
| Ventilator derived positive pressure ventilation - V-PPVThe clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. Ventilator delivered positive pressure ventilation (V-PPV) using a nasal interface will be delivered to the infant in the resuscitation room. | Device | Intervention under investigation (Ventilator delivered PPV) |
| T-piece resuscitator (TPR)The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. PPV will be provided with a T-piece resuscitator (Neopuff, Fisher \& Paykel Healthcare) connected to an appropriately sized face-mask. | Device | Control group (T-Piece Resuscitator) |
Primary outcome
Composite of pre-discharge mortality
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Death in NICU
Major neuro-injury
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia.
Moderate-severe BPD
Time frame: At 36 weeks' postmenstrual age.
Defined as 2 L/min nasal cannula or other forms of non-invasive ventilation support or invasive mechanical ventilation.
5 secondary outcomes
Components of the primary outcome
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Frequency of receipt of advanced cardiopulmonary resuscitation measures
Time frame: From enrollment to 1 hour post intervention.
Duration of invasive mechanical ventilation during NICU admission
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Discharge on home oxygen
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Other relevant key prematurity related adverse outcome
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Michelle Baczynski, MSc, RRT principal investigator
MOUNT SINAI HOSPITAL
Amish Jain, MBBS, MRCPCH, PhD principal investigator
MOUNT SINAI HOSPITAL
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator derived positive pressure ventilation - V-PPV and T-piece resuscitator (TPR) in people with Neonatal Resuscitation and Apnea Neonatal, run by Michelle Baczynski at 11 sites in 3 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada, United States, Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thaiani Wulff, BSc (1-416-586-4800. ext. 176746, thaiani.wulff@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of pre-discharge mortality (time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.