780 Participants Needed

T-piece Resuscitator vs Ventilator for Preterm Birth

(MVP Trial)

Recruiting at 8 trial locations
LT
TW
Overseen ByThaiani Wulff, BSc
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Michelle Baczynski
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the T-piece resuscitator safe for use in preterm infants?

The T-piece resuscitator is commonly used worldwide for newborn resuscitation and has been compared to other devices like the self-inflating bag. Studies show that it does not significantly differ in safety outcomes, such as oxygen levels and heart rate, compared to other methods. However, there were some instances of pressure spikes in certain models, which should be monitored.12345

How does Ventilator Positive Pressure Ventilation differ from other treatments for preterm birth?

Ventilator Positive Pressure Ventilation (PPV) is unique because it uses a ventilator to deliver consistent and controlled breaths to preterm infants, which can be more precise compared to manual methods like the T-piece resuscitator or self-inflating bag. This method can help ensure stable oxygen levels and heart rates in newborns during resuscitation.13678

What data supports the effectiveness of the treatment Ventilator Positive Pressure Ventilation for preterm birth?

The research comparing T-piece resuscitator (TPR) and self-inflating bag (SIB) for preterm infants shows that both methods are similar in effectiveness for initial resuscitation, with no significant differences in oxygen saturation or heart rate outcomes. This suggests that positive pressure ventilation, whether delivered by TPR or SIB, is effective in supporting preterm infants immediately after birth.123910

Who Is on the Research Team?

MB

Michelle Baczynski, MSc

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for extremely premature infants born before 28 weeks' gestation who require breathing assistance immediately after birth. The study aims to improve their initial respiratory support and potentially reduce the need for more invasive procedures.

Inclusion Criteria

I am between 25 and 29 weeks pregnant.
Received PPV as determined by the resuscitation team during the first 10 minutes of birth
I am eligible for all life-saving treatments, not just comfort care.

Exclusion Criteria

I have a known significant birth defect or genetic condition.
I breathe on my own without mechanical help.
Outborn birth status
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Immediate Post-Birth Stabilization

Positive pressure ventilation (PPV) is provided using either a T-piece resuscitator or a ventilator in NIPPV mode during the first 10 minutes after birth

10 minutes
1 visit (in-person)

NICU Monitoring

Infants are monitored in the NICU for respiratory support and other health outcomes

Up to 50 weeks postmenstrual age

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ventilator Positive Pressure Ventilation
Trial Overview The trial compares two methods of providing positive pressure ventilation (PPV) to these infants: manual T-piece resuscitator (TPR) and ventilator-derived PPV (V-PPV). It will evaluate which method better prevents major health complications or death during post-birth stabilization.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention under investigation (Ventilator delivered PPV)Experimental Treatment1 Intervention
Group II: Control group (T-Piece Resuscitator)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michelle Baczynski

Lead Sponsor

Trials
1
Recruited
780+

London Health Sciences Centre

Collaborator

Trials
151
Recruited
60,400+

BC Women's Hospital & Health Centre

Collaborator

Trials
15
Recruited
1,010,000+

Montreal Children's Hospital of the MUHC

Collaborator

Trials
32
Recruited
117,000+

St. Justine's Hospital

Collaborator

Trials
205
Recruited
87,300+

Cedars-Sinai Medical Center

Collaborator

Trials
523
Recruited
165,000+

Royal Alexandra Hospital

Collaborator

Trials
20
Recruited
9,300+

Foothills Medical Centre

Collaborator

Trials
21
Recruited
20,200+

McMaster Children's Hospital

Collaborator

Trials
43
Recruited
19,900+

Sunnybrook Health Sciences Centre

Collaborator

Trials
693
Recruited
1,569,000+

Citations

Neopuff T-piece resuscitator: does device design affect delivered ventilation? [2019]
T-Piece resuscitator versus self-inflating bag for delivery room resuscitation in preterm neonates: a randomized controlled trial. [2023]
T-piece versus self-inflating bag ventilation in preterm neonates at birth. [2017]
T-piece or self inflating bag for positive pressure ventilation during delivery room resuscitation: an RCT. [2015]
Assisted ventilation immediately after birth with self-inflating bag versus T-piece resuscitator in preterm infants. [2023]
T-piece resuscitators: can they provide safe ventilation in a low compliant newborn lung? [2021]
Positive end expiratory pressure and respiratory system resistance between self-inflating bag and T-piece resuscitator in a cadaveric piglet lung model. [2022]
Comparison of devices for newborn ventilation in the delivery room. [2014]
T-piece resuscitators: how do they compare? [2019]
Tidal volumes and pressures delivered by the NeoPuff T-piece resuscitator during resuscitation of term newborns. [2022]
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