About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Ventilator derived positive pressure ventilation - V-PPV
DeviceThe 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.
T-piece resuscitator (TPR)
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Composite of pre-discharge mortality
Death in NICU
Major neuro-injury
Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia.
Moderate-severe BPD
Defined as 2 L/min nasal cannula or other forms of non-invasive ventilation support or invasive mechanical ventilation.
Secondary outcomes
Components of the primary outcome
Pre-discharge mortality, major neuro-injury or moderate-severe BPD
Frequency of receipt of advanced cardiopulmonary resuscitation measures
Chest compressions or epinephrine administration for the purpose of resuscitation.
Duration of invasive mechanical ventilation during NICU admission
Total number of days on invasive mechanical ventilation
Discharge on home oxygen
Discharge from the NICU requiring oxygen support at home
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Michelle Baczynski
Lead sponsor
Mount Sinai Hospital, Canada
Sponsor institution
Royal Alexandra Hospital
Collaborator
Foothills Medical Centre
Collaborator
McMaster Children's Hospital
Collaborator
St. Justine's Hospital
Collaborator
Cedars-Sinai Medical Center
Collaborator
Montreal Children's Hospital of the MUHC
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
BC Women's Hospital & Health Centre
Collaborator
Copenhagen University Hospital, Rigshospitalet
Collaborator