Home › Premature Birth › NCT06849596

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

Who can join

25 Weeks – 29 Weeks · All sexes

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

About the study

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.

What is being tested

• Ventilator derived positive pressure ventilation - V-PPV (device)
• T-piece resuscitator (TPR) (device)

Sponsor: Michelle Baczynski · Participants: 780 · Started: Dec 1, 2025

Contact the study team

• Thaiani Wulff, BSc · Phone: 1-416-586-4800.
• Laura Thomas, MSc · Phone: 416-586-4800

Official record on ClinicalTrials.gov — NCT06849596

Locations in the U.S.

Conditions

• Premature Birth

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.