The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05738148
Recruitment Status : Recruiting
First Posted : February 21, 2023
Last Update Posted : November 30, 2023
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Neonatal Drug: Vasopressin Drug: Epinephrine Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cluster-Crossover design
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation - a Cluster Randomized Controlled Phase I Trial
Actual Study Start Date : November 27, 2023
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : January 31, 2026


Arm Intervention/treatment
Active Comparator: 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.
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.

Experimental: 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: 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.




Primary Outcome Measures :
  1. Time to ROSC (Return of spontaneous Circulation) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Within the first 28 days ]
    Number of infants who die until discharge - comparison between group

  2. Number of Patients who have brain injury [ Time Frame: Until infant is discharge from hospital (maximum of 30 weeks after birth) ]
    Brain injury either by ultrasound or magnet resonance imaging - comparison between group

  3. Number of Epinephrine doses during resuscitation [ Time Frame: During resuscitation (up to 60 minutes) ]
    How many doses of epinephrine are given

  4. Number of Vasopressin doses during resuscitation [ Time Frame: During resuscitation (up to 60 minutes) ]
    How many doses of epinephrine are given

  5. Admission temperature [ Time Frame: within 60 minutes after birth ]
    body temperature at admission after birth

  6. Use of therapeutic cooling [ Time Frame: First 72 hours after birth ]
    Number of infants who receive therapeutic cooling during hospital admission

  7. Mode of mechanical ventilation [ Time Frame: Until infant is discharge from hospital (maximum of 30 weeks after birth) ]
    Number of infants who receive mechanical ventilation during hospital admission

  8. Cerebral regional oxygen saturation [ Time Frame: First 72 hours after birth ]
    Changes in Cerebral regional oxygen saturation measured using near-infrared spectrocopy

  9. Mask ventilation in the delivery room [ Time Frame: up to 60 Minutes ]
    Number of infants who receive mask ventilation during chest compression

  10. Intubation in the delivery room [ Time Frame: up to 60 Minutes ]
    Number of infants who were intubated during chest compression

  11. Acute Kidney injury [ Time Frame: 24 hours after birth ]
    To assess serum creatinine and cumulative urine output

  12. Blood gases and serum sodium levels [ Time Frame: 8-12 hours after birth ]
    To assess blood gas values (i.e., pH, paCO2, Base excess) and Sodium blood concertation

  13. Blood gases and serum sodium levels [ Time Frame: 24-28 hours after birth ]
    To assess blood gas values (i.e., pH, paCO2, Base excess) and Sodium blood concertation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   0 Minutes to 20 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05738148


Contacts
Layout table for location contacts
Contact: Georg Schmolzer, MD, PhD 7807354647 schmolze@ualberta.ca

Locations
Layout table for location information
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Georg SCHMOLZER    7807354647    georg.schmoelzer@me.com   
Principal Investigator: Georg Schmolzer         
Sub-Investigator: Po-Yin Cheung         
Sub-Investigator: Caroline Fray         
Sub-Investigator: Brenda Law         
Sponsors and Collaborators
University of Alberta
Investigators
Layout table for investigator information
Principal Investigator: Georg Schmolzer University of Alberta
Layout table for additonal information
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05738148    
Other Study ID Numbers: Pro00122275
First Posted: February 21, 2023    Key Record Dates
Last Update Posted: November 30, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The trial dataset will be stored and maintained at the Royal Alexandra Hospital, where it will be accessible to all trial investigators for quality monitoring.

Other access to the study data will be available by request to the principal investigator.

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Vasopressins
Arginine Vasopressin
Epinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents