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NCT03938532 · ClinicalTrials.gov registry record · NA
Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room
A NA study, sponsored by Baystate Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03938532 is a NA study that was terminated before completion, run by Baystate Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT03938532, a NA study, was terminated before completion, sponsored by Baystate Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
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
Interventions
- DEVICE Volume Targeted Ventilation (VTV) using the Philips Respironics NM3 monitor
- DEVICE Tidal Volume Measurement using the Philips Respironics NM3 monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-07-11 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03938532
The ClinicalTrials.gov registry entry for NCT03938532 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baystate Medical Center, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Volume Targeted Ventilation (VTV) using the Philips Respironics NM3 monitor is the first listed.
NCT03938532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03938532 about?
NCT03938532 is a clinical study titled "Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room". 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...
What is the current status of trial NCT03938532?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2019-07-11. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT03938532?
The interventions under investigation include: Volume Targeted Ventilation (VTV) using the Philips Respironics NM3 monitor (DEVICE), Tidal Volume Measurement using the Philips Respironics NM3 monitor (DEVICE).
Who is sponsoring clinical trial NCT03938532?
This trial is sponsored by Baystate Medical Center, which has 36 total clinical trials registered on ClinicalTrials.gov.
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