Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
MVP
A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial
1 other identifier
interventional
780
3 countries
10
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2024
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
May 6, 2026
April 1, 2026
2.8 years
December 13, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Composite of pre-discharge mortality
Death in NICU
From enrollment through study completion (up to 50 weeks postmenstrual age)
Major neuro-injury
Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia.
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.
At 36 weeks' postmenstrual age.
Secondary Outcomes (5)
Components of the primary outcome
From enrollment through study completion (up to 50 weeks postmenstrual age)
Frequency of receipt of advanced cardiopulmonary resuscitation measures
From enrollment to 1 hour post intervention.
Duration of invasive mechanical ventilation during NICU admission
From enrollment through study completion (up to 50 weeks postmenstrual age)
Discharge on home oxygen
From enrollment through study completion (up to 50 weeks postmenstrual age)
Other relevant key prematurity related adverse outcome
From enrollment through study completion (up to 50 weeks postmenstrual age)
Study Arms (2)
Control group (T-Piece Resuscitator)
ACTIVE COMPARATORPositive 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)
EXPERIMENTALPositive 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michelle Baczynskilead
- Royal Alexandra Hospitalcollaborator
- Sunnybrook Health Sciences Centrecollaborator
- London Health Sciences Centrecollaborator
- Foothills Medical Centrecollaborator
- McMaster Children's Hospitalcollaborator
- St. Justine's Hospitalcollaborator
- Cedars-Sinai Medical Centercollaborator
- BC Women's Hospital & Health Centrecollaborator
- Montreal Children's Hospital of the MUHCcollaborator
Study Sites (10)
Cedars-Sinai Guerin Children's
Los Angeles, California, 90505, United States
Foothills Medical Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
BC Children's and Women's Hospital
Vancouver, British Columbia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital at London Health Sciences Centre
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Montreal Children's Hospital
Montral, Quebec, Canada
CHU Sainte Justine
Montreal, Quebec, Canada
Rigshospitalet Coppenhagen
Copenhagen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Baczynski, MSc
MOUNT SINAI HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The DSMB will assess intervention compliance and mortality rates, masked to the group allocation. The trial statistician will be blinded to group allocations.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Respiratory Therapist
Study Record Dates
First Submitted
December 13, 2024
First Posted
February 27, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share