Ireland
--:--IST
Active, not recruiting Phase 1

Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation

NCT05738148 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1
Started
2023-11-27
Last updated
2026-04-09

Condition(s) studied

Cardiac Arrest Neonatal

Investigational drug(s) / intervention(s)

Vasopressin →Epinephrine →

Vasopressin: "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.

Epinephrine: "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.

Study summary

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.

Eligibility

Sex
ALL
Min age
0 Minutes
Max age
20 Minutes
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to ROSC (Return of spontaneous Circulation) — up to 60 Minutes of chest compression
    Duration of Chest Compression until heart rate increases to greater 60 beats per minute, which is maintained for 60sec.

Trial sites (1)

FacilityCityRegionStatus
Royal Alexandra Hospital Edmonton Alberta
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05738148 on ClinicalTrials.gov ↗ ← All trials in Canada