Comparing Vasopressin and Epinephrine for Newborn CPR
Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation - a Cluster Randomized Controlled Phase I Trial
PHASE1 · University of Alberta · NCT05738148
This study is testing whether vasopressin or epinephrine works better during CPR for newborns who are born without a heartbeat or with a very low heart rate.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 0 Minutes to 20 Minutes |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05738148 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of vasopressin versus epinephrine during cardiopulmonary resuscitation (CPR) in newborns who are born without a heartbeat or with a low heart rate. The study will randomize infants at the Royal Alexandra Hospital to receive either vasopressin or epinephrine during CPR over the course of one year. The primary goal is to determine which medication is more effective in achieving a return of spontaneous circulation, defined as a heart rate greater than 60 beats per minute for at least 60 seconds. This is the first trial of its kind specifically focused on neonatal CPR.
Who should consider this trial
Good fit: Ideal candidates for this study are term or preterm infants born without a heartbeat or with bradycardia.
Not a fit: Patients with congenital heart disease or conditions adversely affecting breathing or ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and outcomes for newborns requiring CPR.
How similar studies have performed: This approach is novel and has not been previously tested in a clinical trial setting for neonatal CPR.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria Infants (term or preterm infants) born without heart beat or with bradycardia Exclusion criteria: Congenital heart disease (e.g., hypo-plastic left heart) Condition that have adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia), o
Where this trial is running
Edmonton, Alberta
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Georg Schmolzer — University of Alberta
- Study coordinator: Georg Schmolzer, MD, PhD
- Email: schmolze@ualberta.ca
- Phone: 7807354647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Arrest Neonatal