Sponsor:
Michelle Baczynski
Code:
NCT06849596
Conditions
Neonatal Resuscitation
Apnea Neonatal
Eligibility Criteria
Sex: All
Age: 0
Healthy Volunteers: Not accepted
Interventions
Ventilator derived positive pressure ventilation - V-PPV
T-piece resuscitator (TPR)
Brief summary:
Conditions
Neonatal Resuscitation
Apnea Neonatal
Study ID
NCT06849596
Start date
Dec 1, 2025
Status verified date
Jun, 2026
Completion date
Jan 1, 2029
Anticipated
Primary completion date
Sep 30, 2028
Anticipated
Eligibility Criteria
Sex: All
Age: 0
Healthy Volunteers: Not accepted
Enrollment
780 participants
Anticipated
Allocation
Randomized
Intervention Model
Crossover
Primary purpose
Treatment
Arms
active comparator: Control group (T-Piece Resuscitator)
experimental: Intervention under investigation (Ventilator delivered PPV)
Interventions
Ventilator derived positive pressure ventilation - V-PPV
T-piece resuscitator (TPR)
Primary outcome measure
Central contacts
Locations
Cedars-Sinai Guerin Children's
Recruiting
Los Angeles, California, United States, 90505
Contacts
Principal Investigator:
Manoj Biniwale, MD
Foothills Medical Centre
Recruiting
Calgary, Alberta, Canada
Contacts
Principal Investigator:
Amuchou Soraisham, MD
Royal Alexandra Hospital
Recruiting
Edmonton, Alberta, Canada
Contacts
Principal Investigator:
Georg Schmölzer, MD
McMaster Children's Hospital
Recruiting
Hamilton, Ontario, Canada
Contacts
Principal Investigator:
Amit Mukerji, MD
Mount Sinai Hospital
Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contacts
Principal Investigator:
Michelle Baczynski, MSc
Montreal Children's Hospital
Recruiting
Montral, Quebec, Canada
Contacts
Principal Investigator:
Marc Beltempo, MD
CHU Sainte Justine
Recruiting
Montreal, Quebec, Canada
Contacts
Principal Investigator:
Ahmed Moussa, MD
Sponsor
Michelle Baczynski
Last update posted
Jun 11, 2026
Last verified
Jun, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michelle Baczynski on 2026-06-11.