T-piece Resuscitator vs Ventilator for Preterm Birth

(MVP Trial)

Recruiting at 8 trial locations

Overseen By Thaiani Wulff, BSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Michelle Baczynski

Disqualifiers: Outborn birth, Major anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

780 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 8 9 10}

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.

Research Team

Michelle Baczynski, MSc

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Intervention under investigation (Ventilator delivered PPV) Experimental Treatment 1 Intervention

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.

Group II: Control group (T-Piece Resuscitator) Active Control 1 Intervention

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.

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Neopuff T-piece resuscitator: does device design affect delivered ventilation? [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

T-Piece resuscitator versus self-inflating bag for delivery room resuscitation in preterm neonates: a randomized controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

T-piece versus self-inflating bag ventilation in preterm neonates at birth. [2017]

4. Ireland pubmed.ncbi.nlm.nih.gov

T-piece or self inflating bag for positive pressure ventilation during delivery room resuscitation: an RCT. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Assisted ventilation immediately after birth with self-inflating bag versus T-piece resuscitator in preterm infants. [2023]

6. England pubmed.ncbi.nlm.nih.gov

T-piece resuscitators: can they provide safe ventilation in a low compliant newborn lung? [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Positive end expiratory pressure and respiratory system resistance between self-inflating bag and T-piece resuscitator in a cadaveric piglet lung model. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of devices for newborn ventilation in the delivery room. [2014]

9. England pubmed.ncbi.nlm.nih.gov

T-piece resuscitators: how do they compare? [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

Tidal volumes and pressures delivered by the NeoPuff T-piece resuscitator during resuscitation of term newborns. [2022]