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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
780
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.
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.
Cedars-Sinai Guerin Children's
Los Angeles, California, United States
NOT_YET_RECRUITINGFoothills Medical Centre
Calgary, Alberta, Canada
RECRUITINGRoyal Alexandra Hospital
Edmonton, Alberta, Canada
NOT_YET_RECRUITINGBC Children's and Women's Hospital
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGMcMaster Children's Hospital
Hamilton, Ontario, Canada
RECRUITINGChildren's Hospital at London Health Sciences Centre
London, Ontario, Canada
NOT_YET_RECRUITINGMount Sinai Hospital
Toronto, Ontario, Canada
RECRUITINGMontreal Children's Hospital
Montral, Quebec, Canada
NOT_YET_RECRUITINGCHU Sainte Justine
Montreal, Quebec, Canada
NOT_YET_RECRUITINGRigshospitalet Coppenhagen
Copenhagen, Denmark
NOT_YET_RECRUITINGComposite of pre-discharge mortality
Death in NICU
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Major neuro-injury
Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia.
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Moderate-severe BPD
Defined as 2 L/min nasal cannula or other forms of non-invasive ventilation support or invasive mechanical ventilation.
Time frame: At 36 weeks' postmenstrual age.
Components of the primary outcome
Pre-discharge mortality, major neuro-injury or moderate-severe BPD
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Frequency of receipt of advanced cardiopulmonary resuscitation measures
Chest compressions or epinephrine administration for the purpose of resuscitation.
Time frame: From enrollment to 1 hour post intervention.
Duration of invasive mechanical ventilation during NICU admission
Total number of days on invasive mechanical ventilation
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Discharge on home oxygen
Discharge from the NICU requiring oxygen support at home
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Other relevant key prematurity related adverse outcome
Necrotizing enterocolitis ≥ stage 2a, retinopathy of prematurity needing treatment.
Time frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
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