Active not recruitingPHASE1INTERVENTIONAL

Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation

When a baby is born with a very slow or no heartbeat, doctors perform CPR, which includes chest compressions and sometimes medicine. Currently, epinephrine is the main medicine used. This study wants to find out if another medicine called vasopressin could be more helpful for these babies. It's the first study to compare these two medicines during newborn CPR. Hospitals taking part will use either epinephrine or vasopressin for one year. The goal is to see which medicine helps babies' hearts recover faster and improves their chances of a good outcome. This could lead to better care for newborns needing urgent help.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University of Alberta

Enrolment target

Start

27 Nov 2023

Estimated completion

28 Feb 2028

Cardiac Arrest Neonatal

What is this study about?

When a baby is just born, their heart should start beating strongly. But sometimes, a baby's heart rate is very slow or stops altogether. When this happens, doctors and nurses give urgent help, known as cardiopulmonary resuscitation or CPR. This involves gently pressing on the baby's chest and helping them breathe. Sometimes, they also need to give medicine to help the heart beat faster.

The most common medicine used is called epinephrine. However, some doctors wonder if another medicine, called vasopressin, might be even better for newborns. Right now, there isn't much information from studies comparing these two medicines specifically in newborn babies during CPR. Most of what doctors know comes from studies on adults or animals, which might not be entirely right for tiny babies.

This study aims to fill that gap. It's the very first study to directly compare vasopressin and epinephrine when used during CPR for newborns. By doing this, doctors hope to understand which medicine helps babies' hearts recover more quickly and improves their overall health outcomes. This research is incredibly important because it could help doctors make better decisions about how to care for the most fragile newborns.

Key takeaways

This study compares two medicines (epinephrine and vasopressin) for newborns needing CPR at birth.
It aims to find out which medicine helps a baby's heart recover fastest.
Participation involves receiving one of the medicines as part of urgent care, not as an extra treatment.
The study could lead to better guidelines for helping babies with a very low or no heartbeat.
No extra tests or procedures are involved beyond standard care.
It focuses on babies from birth up to 20 minutes old.

Who may be eligible?

This study is looking for newborn babies who are born without a heartbeat or with a very slow heartbeat.

However, some babies would not be able to take part. This includes babies who have certain heart problems from birth, like a condition where part of their heart didn't form properly. Also, babies with other severe health problems that affect their breathing, such as a hole in their diaphragm (the muscle that helps with breathing), wouldn't be included.

The study focuses on babies from birth up to 20 minutes old, regardless of whether they are full-term or born early. The medical team will check if your baby fits these criteria if they need CPR at birth.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my baby a newborn (up to 20 minutes old)?
Does my baby have a very slow or no heartbeat at birth, requiring CPR?
Does my baby have any serious heart conditions present since birth?
Does my baby have any other severe congenital conditions affecting their breathing?

Answer every question to see your result.

What does participation involve?

If your baby might be eligible for this study, it means they need CPR right after birth because their heart rate is too low or their heart has stopped. The hospital where your baby is born will be using either epinephrine or vasopressin for all babies needing CPR for a whole year. This means your baby will receive the medicine allocated to that hospital for that year – it's not a choice made at the time for your baby. The medical team will give the medicine as part of the emergency care. There aren't any extra visits or tests for the study beyond the standard care your baby would receive. The study will look at information already collected by the medical team about how your baby responded to the treatment. The total duration of your baby's involvement would be during and immediately after the resuscitation, and the study would then follow their medical records over time to understand their recovery.

Potential risks and benefits

The potential benefit of this study is that it might help doctors find the most effective medicine for newborns needing CPR, potentially improving their chances of survival and recovery. There are no additional risks beyond the standard medical care your baby would receive during this emergency situation, as both medications are routinely used in medical settings. You always have the right to withdraw your baby's data from the study at any time without affecting their medical care.

Locations (1)

Royal Alexandra Hospital
Verified postcode
Edmonton, Canada

Common questions

What is CPR for newborns?

It's emergency care, including chest presses and help with breathing, for babies born with a very slow or no heartbeat.

What two medicines are being compared?

Doctors are comparing epinephrine and vasopressin to see which works better for newborns needing CPR.

Will my baby get special treatment?

No, your baby will receive the standard emergency care, but the hospital will be using one of the two study medicines.

Is this medicine new?

Both medicines are already used in medical care, but this is the first time they are directly compared for newborns during CPR.

Why is this study important?

It could help doctors understand how to give the best urgent care to babies needing help with their heart at birth.