Clinical trial NCT06849596: Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Official title: A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neonatal Resuscitation
Apnea Neonatal
Keywords: Premature Infant
Preterm Neonates
Oxygen
Lung Injury
Respiration, Artificial
Resuscitation
Ventilator, Mechanical
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Royal Alexandra Hospital
name: Foothills Medical Centre
name: McMaster Children's Hospital
name: St. Justine's Hospital
name: Cedars-Sinai Medical Center
name: Montreal Children's Hospital of the MUHC
name: Sunnybrook Health Sciences Centre
name: London Health Sciences Centre
name: BC Women's Hospital & Health Centre
First posted: 2025-02-27
Enrollment: 780
Sex: ALL
Minimum age (years): 25
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will be a cluster-crossover, unmasked randomized control trial (RCT) comparing the clinical effectiveness of two existing methods for providing PPV to preterm neonates born 25+0 to 28+6 weeks gestational age during initial resuscitation after birth.
Primary purpose: TREATMENT

Brief summary: Many extremely premature infants, born before 28 weeks' gestation age, 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: 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

Primary outcomes:
measure: Composite of pre-discharge mortality
timeFrame: From enrollment through study completion (up to 50 weeks postmenstrual age)
measure: Major neuro-injury
timeFrame: From enrollment through study completion (up to 50 weeks postmenstrual age)
measure: Moderate-severe BPD
timeFrame: At 36 weeks' postmenstrual age.
Secondary outcomes:
measure: Components of the primary outcome
timeFrame: From enrollment through study completion (up to 50 weeks postmenstrual age)
measure: Frequency of receipt of advanced cardiopulmonary resuscitation measures
timeFrame: From enrollment to 1 hour post intervention.
measure: Duration of invasive mechanical ventilation during NICU admission
timeFrame: From enrollment through study completion (up to 50 weeks postmenstrual age)
measure: Discharge on home oxygen
timeFrame: From enrollment through study completion (up to 50 weeks postmenstrual age)
measure: Other relevant key prematurity related adverse outcome
timeFrame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Guerin Children's
state: California
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's and Women's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital at London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montral
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: CHU Sainte Justine
state: Quebec
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Michelle Baczynski, MSc
role: PRINCIPAL_INVESTIGATOR
References: