Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation

NCT05738148 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: Pro00122275
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrest Neonatal

Outcome Measures

Primary Outcomes (1)

• Time to ROSC (Return of spontaneous Circulation)

  Duration of Chest Compression until heart rate increases to greater 60 beats per minute, which is maintained for 60sec.

  up to 60 Minutes of chest compression

Secondary Outcomes (13)

• Mortality

  Within the first 28 days

• Number of Patients who have brain injury

  Until infant is discharge from hospital (maximum of 30 weeks after birth)

• Number of Epinephrine doses during resuscitation

  During resuscitation (up to 60 minutes)

• Number of Vasopressin doses during resuscitation

  During resuscitation (up to 60 minutes)

• Admission temperature

  within 60 minutes after birth

Study Arms (2)

Epinephrine

ACTIVE COMPARATOR

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.

Drug: Epinephrine

Vasopressin

EXPERIMENTAL

"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: Vasopressin

Interventions

Vasopressin DRUG

"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.

Vasopressin

Epinephrine DRUG

"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.

Epinephrine

Eligibility Criteria

• Age: 0 Minutes - 20 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Congenital heart disease (e.g., hypo-plastic left heart) Condition that have adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia), o

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (1)

• Ramsie M, Cheung PY, Law B, Schmolzer GM. 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. Resusc Plus. 2023 Aug 31;16:100459. doi: 10.1016/j.resplu.2023.100459. eCollection 2023 Dec.

  PMID: 37663146 DERIVED

MeSH Terms

Interventions

Vasopressins; Epinephrine

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Georg Schmolzer

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-Crossover design

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: November 27, 2023
• Primary Completion: January 13, 2026
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: study protocol and ICF are available upon request, SAP and analytic code in 2027
• Access Criteria: Data requestors seeking to use trial data to generate new publications or presentations will be asked to submit a proposal that will be reviewed by the principal investigator and co-investigators.

Locations

CA (1)