A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 780
- Locations
- 20
- Primary Endpoint
- Composite of pre-discharge mortality
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The DSMB will assess intervention compliance and mortality rates, masked to the group allocation. The trial statistician will be blinded to group allocations.
Eligibility Criteria
- Ages
- 25 Weeks to 29 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group (T-Piece Resuscitator)
Positive pressure ventilation during the first 10 minutes after birth will be provided with a T-Piece Resuscitator (TPR; Neopuff, Fisher & Paykel Healthcare) connected to an appropriately sized face-mask, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites.
Intervention: T-piece resuscitator (TPR) (Device)
Intervention under investigation (Ventilator delivered PPV)
Positive pressure ventilation (PPV) during the first 10 minutes after birth will be provided using a neonatal ventilator set up in noninvasive positive pressure ventilation (NIPPV) mode, connected to an appropriately sized nasal mask or prongs and a dual limb neonatal ventilator circuit, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, respiratory rate and inspiratory time and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites.
Intervention: Ventilator derived positive pressure ventilation - V-PPV (Device)
Outcomes
Primary Outcomes
Composite of pre-discharge mortality
Time Frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Death in NICU
Major neuro-injury
Time Frame: From enrollment through study completion (up to 50 weeks postmenstrual age)
Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia.
Moderate-severe BPD
Time Frame: At 36 weeks' postmenstrual age.
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(From enrollment through study completion (up to 50 weeks postmenstrual age))
- Frequency of receipt of advanced cardiopulmonary resuscitation measures(From enrollment to 1 hour post intervention.)
- Duration of invasive mechanical ventilation during NICU admission(From enrollment through study completion (up to 50 weeks postmenstrual age))
- Discharge on home oxygen(From enrollment through study completion (up to 50 weeks postmenstrual age))
- Other relevant key prematurity related adverse outcome(From enrollment through study completion (up to 50 weeks postmenstrual age))
Investigators
Michelle Baczynski
Respiratory Therapist
Mount Sinai Hospital, Canada