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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Despite significant improvement in preterm infant survival, the incidence of bronchopulmonary dysplasia (BPD) in infants born \< 28 weeks gestational age (GA) has been relatively stable at \~40%, with 10,000-15,000 new cases estimated annually. Delivery room (DR) management of preterm infants during the initial resuscitation has a significant impact on future development of BPD. Current DR practice as recommended by the Neonatal Resuscitation Program (NRP), focuses on providing positive pressure ventilation (PPV) for intubated infants based on pressure limited ventilation (PLV). But with rapidly changing pulmonary compliance during the early newborn period, PLV may lead to under or over inflation of the lungs and induce significant volutrauma, barotrauma and/or atelectotrauma, all of which are associated in the pathogenesis of BPD. No studies have specifically reported tidal volume (TV) provided in the DR in intubated infants with current PLV practices. Similarly, no study has evaluated the safety and efficacy of volume targeted ventilation (VTV) in the DR and its impact on BPD. With the proposed study, in Phase I, the investigators aim to demonstrate that measuring TV in intubated infants receiving PPV via PLV is feasible. The investigators also seek to demonstrate that with PLV, TV is highly variable in the first few hours of life, even with the same peak inspiratory pressures (PiP) due to rapidly changing pulmonary compliance. A successful Phase I will demonstrate that measuring TV is feasible in the DR, and with information on real time actual TV achieved during PPV, it is possible to target the TV for a goal TV by adjusting the PiP provided. Phase II will be a pilot randomized control trial to demonstrate feasibility of VTV compared to PLV. The investigators will also aim to understand the pulmonary mechanics and physiology during VTV. A successful Phase II will demonstrate VTV is feasible, is associated with stable TV, decreased peak inspiratory pressure and oxygen needs compared to PLV, and not associated with increased complications compared to PLV. It will thereby justify a larger randomized control trial with enough power to evaluate the efficacy of VTV in reducing BPD and other long term pulmonary morbidities for preterm infants.

Research Team

Ruben Vaidya, MD

Principal Investigator

Baystate Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+