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Vasoconstrictor

Vasopressin vs. Epinephrine for Neonatal Cardiac Arrest

Phase 1

Recruiting

Led By Georg Schmolzer

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infants (term or preterm infants) born without heart beat or with bradycardia

Be younger than 18 years old

Must not have

Congenital heart disease (e.g., hypo-plastic left heart)

Condition that have adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 60 minutes after birth

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare epinephrine and vasopressin during CPR to see which is more effective in newborn babies when they are born with a low heart rate or no heart rate.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from either medication can include changes in blood pressure, abnormal heart rhythm, and possibly reduced blood flow to certain organs due to their effects on the cardiovascular system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was born with a heart condition.

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I have a condition that makes it hard for me to breathe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 60 minutes after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 60 minutes after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 60 minutes after birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to ROSC (Return of spontaneous Circulation)

Secondary study objectives

Acute Kidney injury

Admission temperature

Blood gases and serum sodium levels

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VasopressinExperimental Treatment1 Intervention

"Vasopressin group" Vasopressin will be via umbilical vein catheter (0.4 IU/kg per dose - first line) or alternatively via an endotracheal tube (8 IU/kg) every three to five minutes as needed with a maximum of two doses if there is no ROSC \[2,3\] After that, the clinical team must convert to give epinephrine (0.02 mg/kg per dose) as long as CPR is ongoing.

Group II: EpinephrineActive Control1 Intervention

Epinephrine group" Epinephrine will be administered according to current resuscitation guidelines either via umbilical vein catheter (0.02 mg/kg per dose) or via endotracheal tube (0.1 mg/kg) every three to five minutes as needed\[2,3\]. Chest compressions and epinephrine will be continued until ROSC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vasopressin

2014

Completed Phase 4

~24780

0 / 3Eligibility criteria met