VOLT-Trial
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants – a randomized controlled trial
Population
Preterm infants 23-28 weeks' gestation requiring respiratory support at birth.
Primary Objective
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
Primary Hypothesis
By using Volume Targeted Ventilation compared to the pressure guided ventilation will improve clinical outcomes in preterm infants.
Design and Sample Size
This pilot randomized controlled trial (RCT) is a two-arm parallel design of two mask ventilation approaches. 50 infants – 25 control / 25 intervention
Inclusion Criteria
Preterm infants 23-28 weeks' gestation requiring respiratory support at birth.
Exclusion Criteria
a) 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.
d) Parents’ refusal to give consent to this study
Efficacy Endpoints
Primary:
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Percentage of preterm infants receiving the intervention [Time Frame: Through study completion (total 18 months)]
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Number of Participants who have received allocated treatment
Secondary:
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All mortality prior to discharge from hospital
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Delivery room interventions
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Admission temperature
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Mechanical ventilation
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Use of inotropes
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Infection/sepsis
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Necrotizing enterocolitis
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Pneumothorax
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Bronchoplumonary dysplasia
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Retinopathy of prematurity
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Brain injury as indicated by abnormal neuroimaging
Safety Evaluations
Adverse events
Statistical Methodology
The final analysis will be conducted after the study is completed, unblinded, and the database is released for analysis. All analyses will be performed using IBM SPSS Statistics Ver. 24 (IBM Corp.) and SAS version 9.4 (SAS Institute Inc.) or later.
Clinical Centers
Canada
Enrolment Period: 1 years
ClinicalTrials.Gov Trial: NCT05144724