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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hopital Beaujon Clichy France
Centre Hospitalier De Saint-Denis St Denis France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Ctaeti Hlgrqamgcxx Dt Tvzbpk Troyes France
Ccxbkd Hpcchzneyay Uzasqjrqcihat Dw Dzarh Dijon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.02.2025

Trial locations

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.

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 ID:
2024-515249-41-00
Protocol code:
CHRD 2419
Trial Phase:
Therapeutic use (Phase IV)

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