T-piece Resuscitator vs Ventilator for Preterm Birth

(MVP Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to assist extremely premature babies with breathing immediately after birth. One method uses a T-piece resuscitator, while the other employs a ventilator to deliver air more precisely through a nasal mask, providing positive pressure ventilation. The researchers aim to determine if the ventilator method reduces the need for more invasive procedures like intubation, which can be risky. Babies born between 25 and 28 weeks who require breathing assistance in the first 10 minutes after birth may be suitable for this trial. The goal is to identify the best approach to improve health outcomes for these vulnerable infants. As an unphased trial, this study offers a unique opportunity to contribute to vital research that could enhance breathing support for premature infants.

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 prior data suggests that using a ventilator for positive pressure ventilation is safe for extremely premature infants?

Research has shown that using a ventilator to assist newborns with breathing is generally safe. Studies have found that this method can lower the risk of air leaks and ensure a steady flow of air to the lungs, indicating its safety for babies. Specifically, past studies demonstrated that using a ventilator in this manner reduced the need for more invasive procedures, such as inserting a tube into the windpipe, which can be risky for these delicate infants. Overall, the evidence suggests that using a ventilator is a safe way to help very premature babies breathe immediately after birth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing the T-piece Resuscitator and the Ventilator for preterm birth resuscitation because each offers unique benefits that could improve neonatal outcomes. Unlike traditional resuscitation methods, the ventilator provides positive pressure ventilation through a nasal mask or prongs using adjustable settings, potentially offering more precise control over breathing support. Meanwhile, the T-piece resuscitator is known for its simplicity and ease of use, which can be critical in emergency settings. This trial aims to determine which method is more effective in stabilizing newborns immediately after birth, potentially leading to better, standardized care practices.

What evidence suggests that this trial's treatments could be effective for preterm birth?

This trial will compare the use of a ventilator with a T-piece resuscitator for providing positive pressure ventilation to extremely premature babies immediately after birth. Research has shown that ventilators can be beneficial. Specifically, a recent study found that this method reduced the need for inserting a breathing tube by 28% compared to a T-piece resuscitator. This is significant because inserting a breathing tube can lead to more complications. Hospitals commonly use ventilators to assist premature babies with breathing, and early evidence suggests they might be more effective in those critical first moments after birth. This method may improve health outcomes for these vulnerable infants by offering more precise and adjustable breathing support. ^{1 2 3 4 6}

Who Is on the Research Team?

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

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11177047/

Outcomes after delivery room positive pressure ventilation ... Among 202 infants who received delivery room positive pressure ventilation, 77 (38.1%) received ≤1 min, and 125 (61.9%) received >1 min of positive pressure ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0300957222007547

Ventilation devices for neonatal resuscitation at birth Resuscitation at birth with FPD improves respiratory transition and decreases BPD with a very low to moderate certainty of evidence. There is suggestion of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06849596

NCT06849596 | Manual T-piece Versus Ventilator Positive ... The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth ...

4. karger.com karger.com/neo/article/121/3/288/896534/Positive-Pressure-Ventilation-in-Preterm-Infants

Positive Pressure Ventilation in Preterm Infants in the ... Simulation studies have reported that PPV using a set VT on a ventilator reduced FM leaks and variations in VT delivery [49‒51]. Further studies ...

5. resuscitationjournal.com resuscitationjournal.com/article/S0300-9572(24)00296-X/abstract

A journey towards safe and effective neonatal resuscitation Manual positive pressure ventilation (PPV) is the most critical intervention in neonatal resuscitation. ... preterm infants treated with ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000902

Part 5: Neonatal Resuscitation: 2020 ... Positive-pressure ventilation (PPV) remains the main intervention in neonatal resuscitation. While the science and practices surrounding ...