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Study on the Use of Epinephrine for Newborns with Cardiac Arrest at Birth

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on newborns who experience cardiorespiratory arrest at birth. This is a serious condition where a newborn's heart and breathing stop. The study aims to test a new method of delivering epinephrine, a medication that helps restart the heart, through a procedure called the VOW procedure. This involves inserting a catheter into the umbilical vein through a part of the umbilical cord known as Wharton's jelly. The goal is to see if this method can successfully restart the heart within 90 seconds.

The trial will observe how quickly the VOW procedure can be performed and how effective it is compared to other methods. It will also look at how long it takes for the newborn's heart rate to return to normal after the epinephrine injection. The study will monitor any difficulties or failures during the procedure, such as problems with the umbilical cord or equipment issues, and will record any side effects that occur within 72 hours after the injection.

By gathering this information, the study aims to improve the success rate of resuscitating newborns in the delivery room. The findings could help healthcare professionals better understand the effectiveness of the VOW procedure and potentially improve outcomes for newborns experiencing cardiorespiratory arrest at birth.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    The trial involves newborns who are full-term, meaning they are born at or after 37 weeks of pregnancy.

    The newborn must be in a state where resuscitation is necessary, specifically if they are experiencing circulatory arrest or a very slow heart rate (less than 60 beats per minute).

    The decision to resuscitate the newborn is made according to the guidelines of the European Resuscitation Council 2021.

  2. Step 2

    Initial resuscitation

    Initial steps of cardiopulmonary resuscitation are performed, including establishing effective breathing for the newborn.

    If these steps do not restore normal heart function, an injection of adrenaline is indicated.

  3. Step 3

    Adrenaline administration

    The medication used is ADRENALINE AGUETTANT 1 mg/ml, which is a solution for injection.

    The adrenaline is administered intravenously, meaning it is injected directly into a vein.

    The goal is to achieve a successful resuscitation within 90 seconds using the VOW procedure, which involves umbilical vein catheterization through Wharton's jelly.

  4. Step 4

    Monitoring and evaluation

    The time taken to place the umbilical route and start the adrenaline injection is recorded.

    The time from the start of the procedure to achieving a heart rate greater than 100 beats per minute is measured.

    The frequency of any failures during the procedure is documented, including reasons such as time exceeded or ineffective injection.

  5. Step 5

    Follow-up

    The newborn is monitored for any adverse events in the 72 hours following the injection.

    The mortality rate is assessed at one hour and at hospital discharge or 28 days, whichever comes first.

    The trial aims to model the relationship between the success of the procedure and factors such as the condition of the umbilical cord or the experience of the healthcare provider.

Who can join the trial?

4 criteria

  • The newborn must be **full-term**, which means they are born at or after 37 weeks of pregnancy.
  • A decision must have been made to **resuscitate** the newborn, which means to try to revive them if they are not breathing or their heart is not beating.
  • The newborn must be experiencing **circulatory arrest**, which means their heart has stopped, or they have **deep bradycardia**, which means their heart rate is very low, less than 60 beats per minute. In this case, an **adrenaline injection** is needed in the delivery room. This decision is based on the guidelines from the **European Resuscitation Council (ERC)** 2021, after trying the first steps of **cardiopulmonary resuscitation (CPR)**, including making sure the newborn is getting enough air.
  • The newborn must be covered by a **social security system** or have the right to it, which means they have access to healthcare services.

Who cannot join the trial?

3 criteria

  • Newborns who did not experience a **cardiorespiratory arrest** at birth. This means the baby did not have a problem with their heart and breathing right after being born.
  • Newborns who are not full-term. Full-term means the baby was born after a normal pregnancy length, usually around 37 to 42 weeks.
  • Newborns who do not need an **adrenaline injection**. Adrenaline is a medicine used in emergencies to help the heart start working properly.
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Investigated drugs

Adrenaline: This medication is used in emergency situations to treat severe allergic reactions and cardiac arrest. In this trial, it is used to help newborns with circulatory arrest in the delivery room. Adrenaline works by stimulating the heart and increasing blood flow, which can be crucial in resuscitating a newborn.

What is already known about the treatment

Adrenaline – Adrenaline is typically administered through injection, often in emergency situations. It is currently well-established in medical practice and literature, particularly for its role in emergency medicine. The main therapeutic use of adrenaline is to treat severe allergic reactions, cardiac arrest, and other conditions requiring rapid response. At the molecular level, adrenaline works by stimulating alpha and beta-adrenergic receptors, leading to increased heart rate, improved blood flow, and relaxation of airway muscles. It is classified as a sympathomimetic drug, which means it mimics the effects of the sympathetic nervous system.

Investigated diseases

Cardiorespiratory arrest at birth in full-term newborns – This condition occurs when a newborn's heart and breathing stop at the time of birth. It is a critical situation that requires immediate medical intervention to restore circulation and breathing. The condition can arise due to various factors, including complications during delivery or underlying health issues. Without prompt resuscitation, the lack of oxygen can lead to severe consequences. The progression of this condition is rapid, necessitating quick and effective response measures. The primary goal is to re-establish a normal heart rate and breathing pattern as soon as possible.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IVTrial ID2024-515249-41-00Protocol codeCHRD 2419Estimated enrolment26 patientsSponsorHopital NOVO

sourced from the EU Clinical Trials Register and site verification

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