Back to resultsVolume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants (VOLT)
Primary Purpose
Neonatal Respiratory Distress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Volume targeted ventilation
Pressure targeted ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Respiratory Distress
Eligibility Criteria
Inclusion Criteria:
- Preterm infants 23-28 weeks' gestation requiring respiratory support at birth will be eligible for the trial. Inclusion criteria are pragmatic to enable the inclusion of ELGAN infants (Extremely Low Gestational Age Newborns).
Exclusion Criteria:
- Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia), or congenital heart disease requiring intervention in the neonatal period.
- Infants will also be excluded if their parents refuse to give consent to this study.
Sites / Locations
- Royal Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Volume Targeted Ventilation
Pressure guided Ventilation
Arm Description
Positive pressure ventilation will be provided using a set tidal volume
Positive pressure ventilation will be provided using a set peak inflation pressure
Outcomes
Primary Outcome Measures
Percentage of preterm infants receiving the intervention
Number of Participants who have received allocated treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05144724
Brief Title
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
Acronym
VOLT
Official Title
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room.
Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Volume Targeted Ventilation
Arm Type
Experimental
Arm Description
Positive pressure ventilation will be provided using a set tidal volume
Arm Title
Pressure guided Ventilation
Arm Type
Active Comparator
Arm Description
Positive pressure ventilation will be provided using a set peak inflation pressure
Intervention Type
Procedure
Intervention Name(s)
Volume targeted ventilation
Intervention Description
Positive pressure ventilation will be provided using a set tidal volume
Intervention Type
Procedure
Intervention Name(s)
Pressure targeted ventilation
Intervention Description
Positive pressure ventilation will be provided using a set peak inflation pressure
Primary Outcome Measure Information:
Title
Percentage of preterm infants receiving the intervention
Description
Number of Participants who have received allocated treatment
Time Frame
Through study completion (total 18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Minutes
Maximum Age & Unit of Time
1 Minute
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants 23-28 weeks' gestation requiring respiratory support at birth will be eligible for the trial. Inclusion criteria are pragmatic to enable the inclusion of ELGAN infants (Extremely Low Gestational Age Newborns).
Exclusion Criteria:
Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia), or congenital heart disease requiring intervention in the neonatal period.
Infants will also be excluded if their parents refuse to give consent to this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg Schmölzer, MD, PhD
Phone
+17807354647
Email
georg.schmoelzer@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Law, MD, MSc
Phone
+17807354647
Email
blaw2@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schmölzer, MD, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg SCHMOLZER
Phone
7807354647
Email
georg.schmoelzer@me.com
First Name & Middle Initial & Last Name & Degree
Georg Schmolzer
First Name & Middle Initial & Last Name & Degree
Po-Yin Cheung
First Name & Middle Initial & Last Name & Degree
Caroline Fray
First Name & Middle Initial & Last Name & Degree
Brenda Law
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The protocol will be published in an open access journal and data can be requested from the principal investigator
IPD Sharing Time Frame
Protocol will be published within 18 months
Learn more about this trial
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
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