Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates (MVP)

April 30, 2026 updated by: Michelle Baczynski

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

780

Phase

  • 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 Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
        • Not yet recruiting
        • Royal Alexandra Hospital
        • Contact:
        • Principal Investigator:
          • Georg Schmölzer, MD
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Not yet recruiting
        • BC Children's and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Jonathan Wong, MD
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • McMaster Children's Hospital
        • Contact:
        • Principal Investigator:
          • Amit Mukerji, MD
      • London, Ontario, Canada
        • Not yet recruiting
        • Children's Hospital at London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Kevin Coughlin, MD
      • Toronto, Ontario, Canada, M5G 1X5
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Michelle Baczynski, MSc
        • Principal Investigator:
          • Amish Jain, MD
    • Quebec
      • Montral, Quebec, Canada
        • Recruiting
        • Montreal Children's Hospital
        • Contact:
        • Principal Investigator:
          • Marc Beltempo, MD
      • Montreal, Quebec, Canada
        • Recruiting
        • CHU Sainte Justine
        • Principal Investigator:
          • Ahmed Moussa, MD
        • Contact:
  • Denmark
      • Copenhagen, Denmark
        • Not yet recruiting
        • Rigshospitalet Coppenhagen
        • Contact:
        • Principal Investigator:
          • Christian Heiring, MD
  • United States
    • California
      • Los Angeles, California, United States, 90505
        • Recruiting
        • Cedars-Sinai Guerin Children's
        • Contact:
        • Principal Investigator:
          • Manoj Biniwale, MD

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria::

  • 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

Exclusion Criteria:

  • 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

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group (T-Piece Resuscitator)
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.
Device: 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.
Experimental: Intervention under investigation (Ventilator delivered PPV)
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.
Device: Ventilator derived positive pressure ventilation - V-PPV
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of pre-discharge mortality
Time Frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Death in NICU
From enrollment through study completion (up to 50 weeks postmenstrual age)
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.
From enrollment through study completion (up to 50 weeks postmenstrual age)
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.
At 36 weeks' postmenstrual age.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Components of the primary outcome
Time Frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Pre-discharge mortality, major neuro-injury or moderate-severe BPD
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.
Chest compressions or epinephrine administration for the purpose of resuscitation.
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)
Total number of days on invasive mechanical ventilation
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)
Discharge from the NICU requiring oxygen support at home
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)
Necrotizing enterocolitis ≥ stage 2a, retinopathy of prematurity needing treatment.
From enrollment through study completion (up to 50 weeks postmenstrual age)

Collaborators and Investigators

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

Sponsor

Michelle Baczynski

Collaborators

Sunnybrook Health Sciences Centre
Cedars-Sinai Medical Center
London Health Sciences Centre
McMaster Children's Hospital
St. Justine's Hospital
Royal Alexandra Hospital
Montreal Children's Hospital of the MUHC
Foothills Medical Centre
BC Women's Hospital & Health Centre

Investigators

  • Principal Investigator: Michelle Baczynski, MSc, Mount Sinai Hospital

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)

December 1, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO 5018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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