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Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room

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ClinicalTrials.gov Identifier: NCT03938532
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ruben, Baystate Medical Center

Brief 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 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.


Condition or disease Intervention/treatment Phase
Prematurity BPD - Bronchopulmonary Dysplasia Respiratory Distress Syndrome, Newborn Device: Volume Targeted Ventilation (VTV) using the Philips Respironics NM3 monitor Device: Tidal Volume Measurement using the Philips Respironics NM3 monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 parallel arm
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility and Impact of Volume Targeted Ventilation for Preterm Infants Born <32 Weeks Gestational Age With Need for Invasive Positive Pressure Ventilation in the Delivery Room in Reducing Neonatal Pulmonary Morbidities
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: Control Arm
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
Device: Tidal Volume Measurement using the Philips Respironics NM3 monitor
Tidal Volume Measurement using the Philips Respironics NM3 monitor

Experimental: Intervention Arm
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
Device: Volume Targeted Ventilation (VTV) using the Philips Respironics NM3 monitor
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




Primary Outcome Measures :
  1. Timing of initiation of mechanical ventilation [ Time Frame: First 5 mins of life ]
    The timing of initiation of VTV will be similar to PLV



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Ages Eligible for Study:   up to 60 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age < 32 weeks of gestation
  • Infant born at Baystate Medical Center
  • Requiring intubation and positive pressure ventilation in the delivery room
  • Parental Consent

Exclusion Criteria:

  • Maternal prolonged rupture of membrane > 2 weeks duration
  • Known congenital or cardiac abnormalities or discovered in the immediate neonatal period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938532


Contacts
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Contact: Ruben Vaidya, MD 4137942400 ruben.vaidyaMD@baystatehealth.org
Contact: Rachana Singh, MD 4137942400 rachana.singhMD@baystatehealth.org

Locations
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United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Jennifer Pacheco    413-794-3458    Jennifer.Pacheco@baystatehealth.org   
Sponsors and Collaborators
Baystate Medical Center
Investigators
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Principal Investigator: Ruben Vaidya, MD Baystate Medical Center
  Study Documents (Full-Text)

Documents provided by Ruben, Baystate Medical Center:
Informed Consent Form  [PDF] March 15, 2019

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Responsible Party: Ruben, Assistant Professor of Pediatrics, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT03938532    
Other Study ID Numbers: BH-19-006
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchopulmonary Dysplasia
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury