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Search / Trial NCT06849596

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

Premature Infant Preterm Neonates Oxygen Lung Injury Respiration, Artificial Resuscitation Ventilator, Mechanical

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.

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

0 patients applied

Trial Officials

Michelle Baczynski, MSc

Principal Investigator

MOUNT SINAI HOSPITAL

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported