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ACTIVE NOT RECRUITING
NCT05738148
PHASE1

Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation

Sponsor: University of Alberta

View on ClinicalTrials.gov

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.

Official title: Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation - a Cluster Randomized Controlled Phase I Trial

Key Details

Gender

All

Age Range

0 Minutes - 20 Minutes

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2023-11-27

Completion Date

2028-02-28

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (1)

Royal Alexandra Hospital

Edmonton, Alberta, Canada