T-piece Resuscitator vs Ventilator for Preterm Birth (MVP Trial)

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen ByMichelle Baczynski, MSc

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Michelle Baczynski

No Placebo Group

Trial Summary

What is the purpose of this trial?Many extremely premature infants, born before 28 weeks' gestation age, 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 Criteria

This trial is for extremely premature infants born before 28 weeks' gestation who require breathing assistance immediately after birth. The study aims to improve their initial respiratory support and potentially reduce the need for more invasive procedures.

Inclusion Criteria

I am between 25 and 29 weeks pregnant.

I am eligible for all life-saving treatments, not just comfort care.

Exclusion Criteria

I was resuscitated in an unexpected location, not in the delivery room.

I have a known significant birth defect or genetic condition.

I breathe on my own without mechanical help.

Participant Groups

The trial compares two methods of providing positive pressure ventilation (PPV) to these infants: manual T-piece resuscitator (TPR) and ventilator-derived PPV (V-PPV). It will evaluate which method better prevents major health complications or death during post-birth stabilization.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention under investigation (Ventilator delivered PPV)Experimental Treatment1 Intervention

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.

Group II: Control group (T-Piece Resuscitator)Active Control1 Intervention

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.