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

NANot yet recruitingINTERVENTIONAL
Enrollment

780

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

January 1, 2029

Conditions
Neonatal ResuscitationApnea Neonatal
Interventions
DEVICE

Ventilator derived positive pressure ventilation - V-PPV

The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. Ventilator delivered positive pressure ventilation (V-PPV) using a nasal interface will be delivered to the infant in the resuscitation room.

DEVICE

T-piece resuscitator (TPR)

The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. PPV will be provided with a T-piece resuscitator (Neopuff, Fisher \& Paykel Healthcare) connected to an appropriately sized face-mask.

Trial Locations (9)

90505

Cedars-Sinai Guerin Children's, Los Angeles

Unknown

Foothills Medical Centre, Calgary

Royal Alexandra Hospital, Edmonton

BC Children's and Women's Hospital, Vancouver

McMaster Children's Hospital, Hamilton

Children's Hospital at London Health Sciences Centre, London

Montreal Children's Hospital, Montral

CHU Sainte Justine, Montreal

M5G 1X5

Mount Sinai Hospital, Toronto

All Listed Sponsors
collaborator

Royal Alexandra Hospital

OTHER

collaborator

Foothills Medical Centre

OTHER

collaborator

McMaster Children's Hospital

OTHER

collaborator

St. Justine's Hospital

OTHER

collaborator

Cedars-Sinai Medical Center

OTHER

collaborator

Montreal Children's Hospital of the MUHC

OTHER

collaborator

Sunnybrook Health Sciences Centre

OTHER

collaborator

London Health Sciences Centre

OTHER

collaborator

BC Women's Hospital & Health Centre

OTHER

lead

Michelle Baczynski

OTHER

NCT06849596 - Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates | Biotech Hunter | Biotech Hunter