The VERSE-trial - Vasopressin vs Epinephrine during cardiopulmonary resuscitation of asphyxiated newborns – a cluster randomized controlled trial
Population
Newborns requiring chest compression and cardiovascular supportive medication in the delivery room.
Primary Objective
Vasopressin will improve short- and long-term outcomes in preterm and term newborns.
Primary Hypothesis
When using Vasopressin during cardiopulmonary resuscitation (CPR), the time needed to achieve return of spontaneous circulation (ROSC) compared to epinephrine will be reduced in asphyxiated newborns.
Design and Sample Size
Prospective single-center cluster randomized controlled trial (RCT) with two alternative cardiovascular supportive medications. 10-20 infants
Inclusion Criteria
Newborns requiring chest compression and cardiovascular supportive medication in the delivery room.
Exclusion Criteria
a) Congenital abnormality
b) Condition that might have an adverse effect on breathing or ventilation (e.g. congenital diaphragmatic hernia)
c) 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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Time to achieve return of spontaneous circulation defined as a heart rate of >60/min for 60sec
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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Use of therapeutic cooling
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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
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Seizure
Safety Evaluations
Adverse events
Statistical Methodology
Interim analyses after every patient enrolled in the Vasopressin group to assess safety. The final analysis will be conducted after the study is completed using intention to treat approach.
Clinical Centers
Canada
Enrolment Period: 2 years
ClinicalTrials.Gov Trial: NCT05738148
Study protocol has been published in ResuscitationPlus in 2023