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

Last updated: November 27, 2025
Sponsor: Michelle Baczynski
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Treatment

T-piece resuscitator (TPR)

Ventilator derived positive pressure ventilation - V-PPV

Clinical Study ID

NCT06849596
CTO 5018
  • Ages 25-29
  • All Genders

Study Summary

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

Inclusion

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 onlycomfort care

  • Received PPV as determined by the resuscitation team during the first 10 minutes ofbirth

Exclusion

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

Total Participants: 780
Treatment Group(s): 2
Primary Treatment: T-piece resuscitator (TPR)
Phase:
Study Start date:
December 01, 2025
Estimated Completion Date:
January 01, 2029

Connect with a study center

  • Foothills Medical Centre

    Calgary, Alberta
    Canada

    Site Not Available

  • Royal Alexandra Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

  • Foothills Medical Centre

    Calgary 5913490, Alberta 5883102
    Canada

    Site Not Available

  • Royal Alexandra Hospital

    Edmonton 5946768, Alberta 5883102
    Canada

    Active - Recruiting

  • BC Children's and Women's Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • BC Children's and Women's Hospital

    Vancouver 6173331, British Columbia 5909050
    Canada

    Site Not Available

  • McMaster Children's Hospital

    Hamilton, Ontario
    Canada

    Site Not Available

  • Children's Hospital at London Health Sciences Centre

    London, Ontario
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • McMaster Children's Hospital

    Hamilton 5969782, Ontario 6093943
    Canada

    Active - Recruiting

  • Children's Hospital at London Health Sciences Centre

    London 6058560, Ontario 6093943
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto 6167865, Ontario 6093943 M5G 1X5
    Canada

    Active - Recruiting

  • CHU Sainte Justine

    Montreal, Quebec
    Canada

    Site Not Available

  • Montreal Children's Hospital

    Montral, Quebec 6115047
    Canada

    Active - Recruiting

  • CHU Sainte Justine

    Montreal 6077243, Quebec 6115047
    Canada

    Site Not Available

  • Rigshospitalet Coppenhagen

    Copenhagen 2618425,
    Denmark

    Site Not Available

  • Cedars-Sinai Guerin Children's

    Los Angeles, California 90505
    United States

    Site Not Available

  • Cedars-Sinai Guerin Children's

    Los Angeles 5368361, California 5332921 90505
    United States

    Site Not Available

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