Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Launched by MICHELLE BACZYNSKI · Feb 25, 2025
Trial Information
Current as of May 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how two different methods of helping extremely premature babies breathe after birth compare. One method uses a T-piece resuscitator, a common device for providing positive pressure ventilation (PPV), while the other method uses a ventilator to give a type of PPV called nasal intermittent positive pressure ventilation (NIPPV). The goal is to see which method is more effective in helping these fragile infants breathe on their own, which could reduce the need for more invasive procedures, like intubation, that carry higher risks.
To be eligible for this study, babies must be born between 25 to 28 weeks of pregnancy and need full resuscitation, meaning they are not just receiving comfort care. The trial is not currently recruiting participants, but if your baby fits these criteria and is among those needing help breathing in the first 10 minutes after birth, they may be considered. The researchers hope that by comparing these two methods, they can improve care and outcomes for these vulnerable infants during their critical transition to life outside the womb.
Gender
ALL
Eligibility criteria
- Inclusion Criteria::
- • GA 25+0 to 28+6 weeks using the best available obstetrical estimate
- • Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care
- • Received PPV as determined by the resuscitation team during the first 10 minutes of birth
- Exclusion Criteria:
- • 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
About Michelle Baczynski
Michelle Baczynski is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the healthcare sector, she focuses on fostering innovative clinical studies that adhere to the highest ethical standards and regulatory compliance. Her leadership emphasizes collaboration among multidisciplinary teams, ensuring that trials are designed and executed effectively to yield reliable results. Michelle's strategic vision and passion for patient-centered care drive her efforts to bring transformative therapies to market, ultimately enhancing the quality of life for individuals affected by various medical conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Edmonton, Alberta, Canada
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Vancouver, British Columbia, Canada
Los Angeles, California, United States
Montral, Quebec, Canada
Montreal, Quebec, Canada
Patients applied
Trial Officials
Michelle Baczynski, MSc
Principal Investigator
MOUNT SINAI HOSPITAL
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported