NCT06849596: MVP

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

Recruiting now NA Last updated 12 January 2026

What this trial tests

NA trial testing Ventilator derived positive pressure ventilation - V-PPV in Neonatal Resuscitation in 780 participants. Currently enrolling.

Timeline

1 December 2025

Primary endpoint
30 September 2028

1 January 2029

Quick facts

Lead sponsor	Michelle Baczynski
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	780
Start date	1 December 2025
Primary completion	30 September 2028
Estimated completion	1 January 2029
Sites	10 locations across Denmark, Canada, United States

Drugs / interventions tested

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

Conditions studied

• Neonatal Resuscitation — all drugs for Neonatal Resuscitation →
• Apnea Neonatal — all drugs for Apnea Neonatal →

Sponsor

Michelle Baczynski

Who can join

Adults 25 Weeks to 29 Weeks, any sex, with Neonatal Resuscitation or Apnea Neonatal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.