Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Start Date
12/1/2025
Completion Date
1/1/2029
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.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Ventilator derived positive pressure ventilation - V-PPV
T-piece resuscitator (TPR)
Conditions
Locations
Cedars-Sinai Guerin Children's
Los Angeles, California 90505
United States
Foothills Medical Centre
Calgary, Alberta
Canada
Royal Alexandra Hospital
Edmonton, Alberta
Canada
BC Children's and Women's Hospital
Vancouver, British Columbia
Canada
McMaster Children's Hospital
Hamilton, Ontario
Canada
Children's Hospital at London Health Sciences Centre
London, Ontario
Canada
Mount Sinai Hospital
Toronto, Ontario M5G 1X5
Canada
Montreal Children's Hospital
Montral, Quebec
Canada
CHU Sainte Justine
Montreal, Quebec
Canada
Rigshospitalet Coppenhagen
Copenhagen,
Denmark