Ongoing Clinical Trials for Cardio-respiratory Arrest in Newborns
Currently, there is one ongoing clinical trial investigating new methods to treat newborns who experience cardio-respiratory arrest at birth. This trial is being conducted in France and focuses on improving the delivery of emergency medication to help restart the heart and breathing in full-term newborns.
Clinical trial locations
Study on the Use of Epinephrine for Newborns with Cardiac Arrest at Birth
This clinical trial is designed to help newborns who experience a life-threatening situation at birth when their heart and breathing suddenly stop. The study tests a new way of giving epinephrine, also known as adrenaline, which is a medication used to restart the heart in emergency situations.
Who can participate:
The trial accepts full-term newborns, meaning babies born at or after 37 weeks of pregnancy. To be included, the baby must need resuscitation because their heart has stopped or is beating very slowly (less than 60 beats per minute). The decision to resuscitate follows the European Resuscitation Council 2021 guidelines and is made after the first steps of cardiopulmonary resuscitation have been tried, including making sure the baby is getting enough air. The newborn must also be covered by a social security system or have the right to healthcare services.
Who cannot participate:
Newborns who did not experience this condition at birth, babies who were born prematurely (before 37 weeks), and those who do not need an adrenaline injection are not eligible for this trial.
What the trial is testing:
The study focuses on a new method called the VOW procedure. This involves inserting a thin tube (catheter) into the umbilical vein through a gel-like substance in the umbilical cord known as Wharton’s jelly. The goal is to deliver epinephrine directly into the bloodstream quickly and effectively. Researchers want to see if this method can successfully restart the heart within 90 seconds, which is faster than other methods currently used.
The trial will measure how quickly healthcare professionals can perform the VOW procedure and how long it takes for the baby’s heart rate to return to normal after the epinephrine injection. The study will also monitor any difficulties during the procedure, such as problems with the umbilical cord or equipment, and record any side effects that occur within 72 hours after the injection. The newborn’s condition will be followed until hospital discharge or 28 days, whichever comes first.
Investigational drug:
The medication being tested is epinephrine (adrenaline), specifically ADRENALINE AGUETTANT 1 mg/ml solution for injection. This medication works by stimulating the heart and increasing blood flow, which is crucial for resuscitating a newborn whose heart has stopped. Epinephrine is already well-established in emergency medicine but is being studied here with a new delivery method to improve outcomes for newborns in the delivery room.
Summary
Currently, only one clinical trial is actively recruiting for newborns with cardio-respiratory arrest at birth. This French trial represents an important effort to improve emergency care in the delivery room by testing a faster and potentially more effective method of administering life-saving medication. The focus on the VOW procedure and umbilical vein catheterization could help healthcare professionals respond more quickly to these critical situations. While epinephrine is already a standard treatment in emergency medicine, this study aims to refine how it is delivered to newborns, potentially saving more lives and improving outcomes for babies experiencing this serious condition at birth.