RecruitingNot ApplicableNCT06849596

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

A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial


Sponsor

Michelle Baczynski

Enrollment

780 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 WeeksMax Age: 29 Weeks

Inclusion Criteria3

  • 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 Criteria4

  • 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

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Interventions

DEVICEVentilator 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.

DEVICET-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.


Locations(10)

Cedars-Sinai Guerin Children's

Los Angeles, California, 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, Canada

Montreal Children's Hospital

Montral, Quebec, Canada

CHU Sainte Justine

Montreal, Quebec, Canada

Rigshospitalet Coppenhagen

Copenhagen, Denmark

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NCT06849596


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