VTV for Bronchopulmonary Dysplasia
What You Need to Know Before You Apply
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.
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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).
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on long-term pulmonary morbidities.
What Are the Treatments Tested in This Trial?
Interventions
- Philips Respironics NM3 monitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baystate Medical Center
Lead Sponsor