VTV for Bronchopulmonary Dysplasia

Overseen By Ruben Vaidya, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baystate Medical Center

Disqualifiers: Congenital abnormalities, Cardiac abnormalities, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist very premature babies who need breathing support immediately after birth. Researchers are testing whether volume targeted ventilation (VTV) can better regulate the air these babies receive compared to the current standard, which can sometimes cause lung damage. The goal is to determine if VTV can make breathing support safer and help reduce bronchopulmonary dysplasia (BPD), a serious lung condition. Babies born before 32 weeks and needing immediate breathing support may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve care for very premature infants.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this ventilation technique is safe for preterm infants?

Research shows that volume-targeted ventilation (VTV) is generally well-tolerated in infants. One study found that infants using VTV experienced fewer issues, such as lung injuries (pneumothoraces), compared to those using pressure-limited ventilation (PLV), and they spent less time on ventilators. Another study demonstrated that using a Philips Respironics NM3 monitor to measure tidal volume (the amount of air moving in and out of the lungs) in newborns is both feasible and safe. This monitor helps adjust air pressure to achieve the right air volume, making breathing support more stable for premature infants.

Since this treatment is being tested in a clinical trial, detailed safety information for this specific use in newborns is still being collected. However, earlier research provides a hopeful view of VTV's safety in assisting infants at risk of bronchopulmonary dysplasia with their breathing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage bronchopulmonary dysplasia (BPD) in infants. Unlike the standard care that provides pressure-regulated breaths without feedback, this trial uses a Philips Respironics NM3 monitor to allow healthcare providers to see and adjust the peak inspiratory pressure (PiP). This visibility enables them to achieve a more precise tidal volume target, which could lead to better respiratory outcomes for these vulnerable infants. By offering a more tailored approach, the trial hopes to improve the effectiveness and safety of mechanical ventilation for newborns with BPD.

What evidence suggests that volume targeted ventilation is effective for bronchopulmonary dysplasia?

Research has shown that volume targeted ventilation (VTV) in premature babies may lead to better health outcomes compared to pressure limited ventilation (PLV). In this trial, infants in the intervention arm will receive VTV, which helps maintain steady breathing by keeping the air volume in each breath consistent. This can reduce the need for high oxygen levels. Stable breathing is crucial as it can help prevent lung injuries that lead to conditions like bronchopulmonary dysplasia (BPD). The Philips Respironics NM3 monitor accurately measures these air volumes, allowing doctors to adjust treatment as needed. Early findings suggest that VTV might reduce the risk of complications without causing additional harm. ^{1 6 7 8 9}

Who Is on the Research Team?

Ruben Vaidya, MD

Principal Investigator

Baystate Medical Center

Are You a Good Fit for This Trial?

This trial is for premature infants born at less than 32 weeks of gestation, who need breathing support right after birth and are delivered at Baystate Medical Center. Parents must consent to participate. Infants with long-term membrane rupture or immediate congenital or cardiac issues can't join.

Inclusion Criteria

You are less than 32 weeks pregnant.

Parental Consent

I needed a breathing tube and mechanical ventilation at birth.

Exclusion Criteria

You have been diagnosed with congenital or heart problems soon after birth.

The mother's water broke more than 2 weeks before the baby was born.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase I - Feasibility Study

Demonstrate feasibility of measuring tidal volume (TV) in intubated infants receiving positive pressure ventilation (PPV) via pressure limited ventilation (PLV) in the delivery room (DR).

First few hours of life

Initial delivery room visit

Phase II - Pilot Randomized Control Trial

Pilot study to demonstrate feasibility of volume targeted ventilation (VTV) compared to PLV, and to understand pulmonary mechanics and physiology during VTV.

First 5 minutes of life

Initial delivery room visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on long-term pulmonary morbidities.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Philips Respironics NM3 monitor

Trial Overview The study tests Volume Targeted Ventilation (VTV) against the usual pressure-limited method in newborns needing ventilation. It aims to show VTV's feasibility, its effect on lung inflation stability, and whether it reduces oxygen needs without increasing risks compared to standard care.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Infants in the intervention arm will receive VTV following intubation. Peak inspiratory pressure (PiP) provided via T-piece resuscitator will be visible to the providers, and the provider can regulate the PiP to achieve the desired TV goal (4-6 ml/kg), at a rate of 40-60 breaths/min

Group II: Control Arm Active Control 1 Intervention

Infant will receive pressure regulated breaths, 40-60 breaths/min, PiP of 20-24cm of water as recommended by 2017 Neonatal Resuscitation Program (NRP) guidelines. Reading of the TV will be blinded from the providers as in routine clinical situations

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7891488/

Physiological dead space and alveolar ventilation in ... An NM3 respiratory profile monitor (Philips Respironics, CT), connected to a combined pressure and flow sensor with mainstream capnograph ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378378222000251

Outcomes following less-invasive-surfactant-administration ... Respiratory monitoring was undertaken for two minutes before and after the LISA using a NM3 respiratory profile monitor (Philips Respironics, Connecticut, USA).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03938532

Feasibility and Impact of Volume Targeted Ventilation in ... The flow sensor will be connected to Respironics NM3 monitor (Philips Healthcare, Eindhoven, Netherlands) to measure the breath to breath TV. The flow sensor ...

4. nature.com nature.com/articles/s41372-021-01113-7

Tidal volume measurements in the delivery room ... The RFM used was Respironics NM3 monitor (Philips Healthcare, Eindhoven, Netherlands), which is a portable device, weighs 4.38 kg with ...

5. kclpure.kcl.ac.uk kclpure.kcl.ac.uk/portal/files/143052955/respiratory_monitoring_during_LISA_Hemant.doc

respiratory monitoring during LISA Hemant The NM3 respiratory profile monitor has a pneumotachograph which monitors combined pressure, flow and EtCO2 and was placed in line with the t-piece. Oxygen ...

6. nature.com nature.com/articles/s41372-018-0240-6

Tidal volume monitoring during emergency neonatal ... For patients enrolled in the study, lung function measurements were recorded using the Philips Respironics NM3 Respiratory Profile Monitor and ...

7. researchgate.net researchgate.net/publication/352297845_Tidal_volume_measurements_in_the_delivery_room_in_preterm_infants_requiring_positive_pressure_ventilation_via_endotracheal_tube-feasibility_study

(PDF) Tidal volume measurements in the delivery room in ... Our previous study demonstrated TV measurement via endotracheal tube (ETT) was feasible in DR in intubated preterm infants using respiratory ...

8. europepmc.org europepmc.org/article/pmc/8191447

Tidal volume measurements in the delivery room ... Prospective, observational, feasibility study in infants <32 weeks GA and intubated in DR. TV was measured using a respiratory function monitor.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21701210/

Volume-targeted versus pressure-limited ventilation for ... Compared with PLV, infants ventilated using volume-targeted ventilation had reduced death/BPD, duration of ventilation, pneumothoraces, hypocarbia and ...