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Study identifier: NCT06849596 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Neonatal Resuscitation · Apnea Neonatal  ·  Sponsor: Michelle Baczynski

PhaseNA
Planned participants780
Who can joinAll sexes, 25 Weeks to 29 Weeks
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Thaiani Wulff, BSc  ·  1-416-586-4800.  ·  thaiani.wulff@sinaihealth.ca

Laura Thomas, MSc  ·  416-586-4800  ·  laura.thomas@sinaihealth.ca

Always discuss trial participation with your own doctor first.

Locations (10)

Cedars-Sinai Guerin Children'sLos Angeles, California, United StatesRecruiting
Foothills Medical CentreCalgary, Alberta, CanadaRecruiting
Royal Alexandra HospitalEdmonton, Alberta, CanadaRecruiting
BC Children's and Women's HospitalVancouver, British Columbia, CanadaNot Yet Recruiting
McMaster Children's HospitalHamilton, Ontario, CanadaRecruiting
Children's Hospital at London Health Sciences CentreLondon, Ontario, CanadaNot Yet Recruiting
Mount Sinai HospitalToronto, Ontario, CanadaRecruiting
Montreal Children's HospitalMontral, Quebec, CanadaRecruiting
CHU Sainte JustineMontreal, Quebec, CanadaRecruiting
Rigshospitalet CoppenhagenCopenhagen, DenmarkNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06849596