Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Recruiting now · Not applicable
Conditions studied: Neonatal Resuscitation, Apnea Neonatal
In brief
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.
Key facts
- Study ID
- NCT06849596
- Run by
- Michelle Baczynski
- People needed
- 780
- Starts
- 2025-12-01
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-06-11
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- Montreal Children's Hospital — Montral, Quebec, Canada (enrolling)
- CHU Sainte Justine — Montreal, Quebec, Canada (enrolling)
- Cedars-Sinai Guerin Children's — Los Angeles, California, United States (enrolling)
- Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (enrolling)
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (enrolling)
- Mount Sinai Hospital — Toronto, Ontario, Canada (enrolling)
- Rigshospitalet Coppenhagen — Copenhagen, Denmark
- BC Children's and Women's Hospital — Vancouver, British Columbia, Canada
- Children's Hospital at London Health Sciences Centre — London, Ontario, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.