Recruiting

V-PPV vs. T-Piece

Sponsor:

Michelle Baczynski

Code:

NCT06849596

Conditions

Neonatal Resuscitation

Apnea Neonatal

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Ventilator derived positive pressure ventilation - V-PPV

T-piece resuscitator (TPR)

Study Details

Brief 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.

Conditions

Neonatal Resuscitation

Apnea Neonatal

Study ID

NCT06849596

Start date

Dec 1, 2025

Status verified date

Jun, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

780 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control group (T-Piece Resuscitator)

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.

experimental: Intervention under investigation (Ventilator delivered PPV)

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.

Interventions

Ventilator 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.

T-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.

Primary outcome measure

  • Composite of pre-discharge mortality [ Time Frame: From enrollment through study completion (up to 50 weeks postmenstrual age) ]
  • Major neuro-injury [ Time Frame: From enrollment through study completion (up to 50 weeks postmenstrual age) ]
  • Moderate-severe BPD [ Time Frame: At 36 weeks' postmenstrual age. ]

Central Contacts and Locations

Locations

Cedars-Sinai Guerin Children's

Recruiting

Los Angeles, California, United States, 90505

Contacts

Principal Investigator:

Manoj Biniwale, MD

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Principal Investigator:

Amuchou Soraisham, MD

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Principal Investigator:

Georg Schmölzer, MD

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada

Contacts

Principal Investigator:

Amit Mukerji, MD

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Principal Investigator:

Michelle Baczynski, MSc

Montreal Children's Hospital

Recruiting

Montral, Quebec, Canada

Contacts

Principal Investigator:

Marc Beltempo, MD

CHU Sainte Justine

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

Ahmed Moussa, MD

More Information

Sponsor

Michelle Baczynski

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Premature Infant
  • Preterm Neonates
  • Oxygen
  • Lung Injury
  • Respiration, Artificial
  • Resuscitation
  • Ventilator, Mechanical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michelle Baczynski on 2026-06-11.