The VERSE-trial - Vasopressin vs Epinephrine during CPR of asphyxiated newborns

Vasopressin vs Epinephrine during cardiopulmonary resuscitation of asphyxiated newborns – a cluster randomized controlled phase I trial

Introduction

Current neonatal resuscitation guidelines recommend the use of epinephrine during neonatal cardiopulmonary resuscitation (CPR). However, newborns receiving epinephrine continue to have high rates of mortality and neurodevelopmental disability. The infrequent need for neonatal CPR, coupled with an inability to consistently anticipate which newborn infants are at risk of requiring CPR, explains the lack of high-quality evidence (i.e., large randomized clinical trials) to better guide healthcare providers in their resuscitative effort. Therefore, we need neonatal data to determine the optimal vasopressor therapy during neonatal CPR. The current pilot trial will examine the efficacy of vasopressin versus epinephrine during CPR of asphyxiated newborn infants.

Methods and analysis

The trial will be a prospective, cluster, open label, single-center, randomized controlled trial on two alternative cardiovascular supportive medications. This study will assess the primary outcome of time to return of spontaneous circulation (ROSC) in newborns requiring CPR in the delivery room who were treated with either vasopressin (intervention) or epinephrine (control). Secondary outcomes such as infant mortality and other clinical outcome measures will also be collected. An estimated 20 newborns will be recruited, and comparisons will be made between asphyxiated infants treated with either drugs.

Ethics and dissemination

This study has been approved by the Research Ethics Board at the University of Alberta (June 16, 2023). Study findings will be published in peer-reviewed journals, presented at conferences, and communicated to relevant participants and stakeholders.

Trial registration:

ClinicalTrial.gov Identifier: NCT05738148. Registered February 21, 2023.

STRENGTHS AND LIMITATIONS OF THIS STUDY

· This trial will use an open label, cluster, single centre randomized controlled trial (RCT) with two alternative cardiovascular supportive medications in the delivery room.

· This trial will examine the differences in time to return of spontaneous circulation and clinical outcome measures in asphyxiated newborns treated with epinephrine vs. vasopressin.

· This trial will be the first neonatal clinical trial to examine the efficacy of vasopressin in the infants’ receiving CPR in the delivery room.

· Due to the low incidence of newborns requiring cardiopulmonary resuscitation at birth, the expected number of participants is expected to be approximately 20.

Check out the link of the open access publication for the full protocol or check the the VERSE-Trial page on https://www.research4babies.org