20 Participants Needed

Vasopressin vs. Epinephrine for Neonatal Cardiac Arrest

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Overseen ByGeorg Schmolzer, MD, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

When a baby is born with a low heart rate or no heart rate, the clinical team must provide breathing support and chest compressions (what is call cardiopulmonary resuscitation or CPR). In some situations, the clinical team also need to give medications to help the heart rate increase. During CPR, the most common medication given is called epinephrine. There is another medication called vasopressin that is available that could be beneficial to newborn babies. However, no study has compared epinephrine with vasopressin in the delivery room during neonatal CPR.The current study will be the first trial comparing this two medications during neonatal CPR.The investigators will randomize our hospital to either epinephrine or vasopressin for the duration of one year. Babies will either receive CPR with epinephrine (this will be the control group) or CPR with vasopressin ( this will be the intervention group). The investigators believe that vasopressin may be more helpful to babies with a low heartrate or no heart rate at birth.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is vasopressin safe compared to epinephrine for neonatal cardiac arrest?

Epinephrine is the recommended treatment for neonatal cardiac arrest, as it has been shown to be more effective than vasopressin in animal studies. Vasopressin has not been proven safe or effective for newborns, and there is insufficient evidence to recommend its use in this age group.12345

How does the drug vasopressin compare to epinephrine for neonatal cardiac arrest?

Vasopressin is being studied as an alternative to epinephrine for neonatal cardiac arrest, but current research suggests that epinephrine is more effective in achieving a quicker return of spontaneous circulation (ROSC). Vasopressin acts as a systemic vasoconstrictor, which can increase blood flow in the lungs, but it has shown a lower success rate and longer time to ROSC compared to epinephrine in animal studies.12367

What data supports the effectiveness of the drug epinephrine compared to vasopressin for neonatal cardiac arrest?

Research shows that epinephrine is more effective than vasopressin in achieving the return of spontaneous circulation (ROSC) in newborn animal models with cardiac arrest. In a study with fetal lambs, epinephrine led to a quicker and more frequent ROSC compared to vasopressin, supporting its use in neonatal resuscitation.12378

Who Is on the Research Team?

Georg Schmolzer | IntechOpen

Georg Schmolzer

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for newborn babies, both full-term and preterm, who are born with a very low heart rate or no heart rate at all. Babies with congenital heart defects like hypo-plastic left heart or conditions that affect breathing such as congenital diaphragmatic hernia cannot participate.

Inclusion Criteria

My baby was born without a heartbeat or with a very slow heart rate.

Exclusion Criteria

I was born with a heart condition.
I have a condition that makes it hard for me to breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either epinephrine or vasopressin during neonatal CPR, with chest compressions and medication administration as per resuscitation guidelines.

up to 60 minutes
In-hospital during delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mortality, brain injury, and other health parameters.

30 weeks
Regular hospital visits until discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Epinephrine
  • Vasopressin
Trial Overview The study compares two medications used during CPR in newborns: vasopressin and epinephrine. Hospitals will use one of these drugs for a year when performing CPR on babies with low or no heartbeat at birth. The goal is to see if vasopressin offers more benefits than the commonly used epinephrine.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: VasopressinExperimental Treatment1 Intervention
Group II: EpinephrineActive Control1 Intervention

Epinephrine is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Epinephrine for:
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Approved in United States as Epinephrine for:
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Approved in Canada as Epinephrine for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Published Research Related to This Trial

This pilot trial will compare the efficacy of vasopressin versus epinephrine in neonatal CPR, focusing on the time to return of spontaneous circulation (ROSC) in asphyxiated newborns, with an estimated 20 participants.
The study aims to provide valuable data on optimal vasopressor therapy during neonatal resuscitation, addressing the high rates of mortality and neurodevelopmental disability associated with current practices.
Vasopressin versus epinephrine during cardiopulmonary resuscitation of asphyxiated newborns: A study protocol for a prospective, cluster, open label, single-center, randomized controlled phase 2 trial - The VERSE-Trial.Ramsie, M., Cheung, PY., Law, B., et al.[2023]
In a study involving 27 term fetal lambs with cardiac arrest induced by umbilical cord occlusion, epinephrine was more effective than vasopressin, achieving return of spontaneous circulation (ROSC) in 7 out of 10 lambs within an average of 8 minutes, while vasopressin only achieved ROSC in 3 out of 9 lambs after an average of 13 minutes.
The findings support current neonatal resuscitation guidelines that recommend the exclusive use of epinephrine, as vasopressin resulted in a lower incidence and longer time to ROSC, indicating it may not be suitable for this purpose.
Masked Randomized Trial of Epinephrine versus Vasopressin in an Ovine Model of Perinatal Cardiac Arrest.Rawat, M., Gugino, S., Koenigsknecht, C., et al.[2023]
In a study involving newborn piglets, vasopressin showed similar effectiveness to epinephrine in achieving return of spontaneous circulation (ROSC) after asphyxial cardiac arrest, with no significant differences in time to ROSC or incidence of ROSC among the groups.
However, piglets treated with vasopressin had a trend towards lower time to ROSC and higher post-ROSC survival rates compared to those treated with epinephrine, suggesting that vasopressin may offer potential benefits that warrant further investigation in human neonatal trials.
Comparison of various vasopressin doses to epinephrine during cardiopulmonary resuscitation in asphyxiated neonatal piglets.Ramsie, M., Cheung, PY., Lee, TF., et al.[2023]

Citations

Vasopressin versus epinephrine during cardiopulmonary resuscitation of asphyxiated newborns: A study protocol for a prospective, cluster, open label, single-center, randomized controlled phase 2 trial - The VERSE-Trial. [2023]
Masked Randomized Trial of Epinephrine versus Vasopressin in an Ovine Model of Perinatal Cardiac Arrest. [2023]
Comparison of various vasopressin doses to epinephrine during cardiopulmonary resuscitation in asphyxiated neonatal piglets. [2023]
The physiologic response to rescue therapy with vasopressin versus epinephrine during experimental pediatric cardiac arrest. [2022]
Vasopressin improves survival compared with epinephrine in a neonatal piglet model of asphyxial cardiac arrest. [2014]
Effects of epinephrine and vasopressin in a piglet model of prolonged ventricular fibrillation and cardiopulmonary resuscitation. [2019]
Medications in neonatal resuscitation: epinephrine and the search for better alternative strategies. [2013]
A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department. [2013]
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