Thanks - Neonatal Resuscitation Program of Canadian Paediatric Society for funding the VERSE-Trial
We would like to thank the Neonatal Resuscitation Program of the Canadian Paediatric Society for awarding us a grant for our pilot cluster trial VERSE - Trial Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation.
This will be a 2 year cluster trial comparing Vasopressin and Epinephrine in the delivery room during chest compression.
Study Title
Epinephrine vs. Vasopressin during cardiopulmonary resuscitation of asphyxiated newborns – a cluster randomized controlled phase I 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 randomized controlled trial (RCT) with two 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:
· Time to achieve return of spontaneous circulation defined as a heart rate of >60/min for 60sec
Secondary:
· All mortality prior to discharge from hospital
· Delivery room interventions
· Admission temperature
· Use of therapeutic cooling
· Mechanical ventilation
· Use of inotropes
· Infection/sepsis
· Necrotizing enterocolitis
· Pneumothorax
· Bronchoplumonary dysplasia
· Retinopathy of prematurity
· Brain injury as indicated by abnormal neuroimaging
· Seizure
· among other outcomes
Safety Evaluations
Adverse events and DSMB including Vishal Kapadia, Gary Wiener, and Karel Allegaert
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 Center
Royal Alexandra Hospital
Enrollment Period
2 years
Study Duration
3 years
ClinicalTrials.Gov Trial
