Actively Recruiting
A Cluster Crossover Randomized Controlled Trial of 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
13 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
Researchers are studying respiratory support methods for extremely premature infants born between 25 and 28 weeks gestational age who need help breathing immediately after birth. The trial compares two positive pressure ventilation (PPV) methods during the first 10 minutes of life: the traditional manual T-piece resuscitator and a ventilator delivering PPV using nasal intermittent positive pressure ventilation (NIPPV). The goal is to see if the ventilator method can reduce major health complications or death in these vulnerable newborns. During the study, infants will receive PPV either with a T-piece resuscitator connected to a face mask or with a neonatal ventilator in NIPPV mode connected to a nasal mask or prongs. Each method will be applied for the first 10 minutes after birth, with treatment settings standardized across sites based on local policies. This randomized trial will be conducted in clusters, with each site using one method during its assigned period. Participants will be monitored up to 50 weeks postmenstrual age for outcomes including mortality before discharge, major brain injury, and moderate to severe bronchopulmonary dysplasia. Additional measures include the use of advanced resuscitation, duration of mechanical ventilation, need for home oxygen, and other prematurity-related complications. The study aims to improve immediate respiratory care and long-term health outcomes for extremely premature infants.
CONDITIONS
Brief 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 based on best obstetrical estimate
- Designated to receive full resuscitation, not comfort care only
- Received positive pressure ventilation within the first 10 minutes after birth as determined by the resuscitation team
You will not qualify if you...
- Born outside the typical delivery room (outborn birth)
- Resuscitation performed in unexpected locations outside the delivery room (e.g., emergency department or antenatal ward)
- Known major congenital or chromosomal anomalies
- Established spontaneous breathing without need for positive pressure ventilation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - First 10 minutes after birth
Participants receive positive pressure ventilation using either a T-piece resuscitator or a ventilator during the first 10 minutes after birth as part of resuscitation.
1 immediate post-birth intervention
Duration - Up to 50 weeks postmenstrual age
Participants are monitored for health outcomes including survival, neuro-injury, and respiratory status until discharge or up to 50 weeks postmenstrual age.
Regular assessments during NICU admission and until discharge
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
L
Laura Thomas, MSc
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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