A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Guerin Children's
NOT_YET_RECRUITING
Los Angeles
Other Locations
Canada
Foothills Medical Centre
NOT_YET_RECRUITING
Calgary
Royal Alexandra Hospital
RECRUITING
Edmonton
McMaster Children's Hospital
RECRUITING
Hamilton
Children's Hospital at London Health Sciences Centre
NOT_YET_RECRUITING
London
Montreal Children's Hospital
RECRUITING
Montral
CHU Sainte Justine
NOT_YET_RECRUITING
Montreal
Mount Sinai Hospital
RECRUITING
Toronto
BC Children's and Women's Hospital
NOT_YET_RECRUITING
Vancouver
Denmark
Rigshospitalet Coppenhagen
NOT_YET_RECRUITING
Copenhagen
Contact Information
Primary
Thaiani Wulff, BSc
thaiani.wulff@sinaihealth.ca
1-416-586-4800.
Backup
Laura Thomas, MSc
laura.thomas@sinaihealth.ca
416-586-4800
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 780
Treatments
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Michelle Baczynski
Collaborators: Foothills Medical Centre, Cedars-Sinai Medical Center, Royal Alexandra Hospital, McMaster Children's Hospital, St. Justine's Hospital, Montreal Children's Hospital of the MUHC, Sunnybrook Health Sciences Centre, London Health Sciences Centre, BC Women's Hospital & Health Centre

This content was sourced from clinicaltrials.gov