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

Michelle Baczynski

Status: Not yet enrolling

Conditions: Apnea Neonatal; Neonatal Resuscitation

Treatments: Device: T-piece resuscitator (TPR); Device: Ventilator derived positive pressure ventilation - V-PPV

Study type: Interventional

Funder types: Other

Identifiers

NCT06849596

CTO 5018

Details and patient eligibility

About

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.

Enrollment: 780 estimated patients

Sex: All

Ages: 25 to 29 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

780 participants in 2 patient groups

Control group (T-Piece Resuscitator)

Active Comparator group

Description:

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.

Treatment:

Device: T-piece resuscitator (TPR)

Intervention under investigation (Ventilator delivered PPV)

Experimental group

Description:

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.

Treatment:

Device: Ventilator derived positive pressure ventilation - V-PPV