Actively Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Led by Michelle Baczynski · Updated on 2026-05-06
780
Participants Needed
10
Research Sites
161 weeks
Total Duration
On this page
Sponsors
M
Michelle Baczynski
Lead Sponsor
R
Royal Alexandra Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age between 25 weeks 0 days and 28 weeks 6 days using the best obstetrical estimate
- Baby is designated to receive full resuscitation, not comfort care only
- Baby received positive pressure ventilation during the first 10 minutes after birth as determined by the resuscitation team
You will not qualify if you...
- Baby was born outside the hospital (outborn birth status)
- Resuscitation performed outside the typical delivery room (e.g., emergency department, antenatal ward)
- Baby has a known major congenital or chromosomal anomaly
- Baby is breathing spontaneously without receiving positive pressure ventilation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Cedars-Sinai Guerin Children's
Los Angeles, California, United States, 90505
Actively Recruiting
2
Foothills Medical Centre
Calgary, Alberta, Canada
Actively Recruiting
3
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Not Yet Recruiting
4
BC Children's and Women's Hospital
Vancouver, British Columbia, Canada
Not Yet Recruiting
5
McMaster Children's Hospital
Hamilton, Ontario, Canada
Actively Recruiting
6
Children's Hospital at London Health Sciences Centre
London, Ontario, Canada
Not Yet Recruiting
7
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
8
Montreal Children's Hospital
Montral, Quebec, Canada
Actively Recruiting
9
CHU Sainte Justine
Montreal, Quebec, Canada
Actively Recruiting
10
Rigshospitalet Coppenhagen
Copenhagen, Denmark
Not Yet Recruiting
Research Team
T
Thaiani Wulff, BSc
CONTACT
L
Laura Thomas, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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