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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


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


· Time to achieve return of spontaneous circulation defined as a heart rate of >60/min for 60sec


· 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


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