Not yet recruitingPHASE2INTERVENTIONAL

Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly

This study is exploring a new way to help newborn babies who are in a critical condition right after birth, experiencing very slow heart rates or their heart has stopped. Sometimes, these babies need adrenaline delivered quickly. The usual method for putting a tube into the umbilical cord to give this medicine can take several minutes, and in these urgent situations, every second counts. Researchers want to see if using a different technique to access the umbilical vein, through a part of the cord called Wharton's jelly, is a quicker, safer, and more effective way to administer the life-saving medicine. The goal is to improve the chances of these babies recovering well.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Hôpital NOVO

Enrolment target

Start

01 Sep 2025

Estimated completion

01 Oct 2027

Newborn Morbidity

What is this study about?

This study is about finding a quicker and easier way to help newborn babies who are in a very serious condition immediately after birth. This can happen if a baby doesn't get enough oxygen during birth, which doctors call 'perinatal anoxia.' Although rare, affecting only 2 to 4 out of every 1000 births, it's a critical emergency. These babies might have extremely slow heart rates or their heart may have stopped, and they need immediate help.

The current guidelines recommend giving a medicine called adrenaline very quickly into a vein. The main way this is done is by putting a small tube, called an umbilical venous catheter, into a vein in the baby's umbilical cord. While this method works, it can be tricky and takes time – sometimes up to 6 minutes, which is a long time when a baby's life is at stake. Researchers are looking for a method that is both fast and safe.

The study aims to see if a slightly different way of putting this tube into the umbilical vein, by going through a part of the umbilical cord called Wharton's jelly, could be a better option. They want to check if this new technique is effective in quickly getting the medicine to the baby, if it's safe for the baby, and if it's practical for doctors to use in emergency situations in the delivery room. The hope is that a quicker method could lead to better outcomes for these vulnerable newborns.

Key takeaways

This study aims to make emergency care for struggling newborns faster.
It focuses on a new way to give life-saving medicine through the umbilical cord.
The goal is to improve safety and effectiveness of this critical procedure.
The study assesses if a different technique for placing a tube in the umbilical vein is better.
Faster access to medicine could lead to better outcomes for babies in distress.

Who may be eligible?

This study is looking for full-term newborn babies, meaning those born at 37 weeks or later. They would be eligible if a medical team has decided they need resuscitation (help to breathe and circulate blood) right after birth. Specifically, this would be for babies whose heart rate is very slow (less than 60 beats per minute) or whose heart has stopped, and they need adrenaline medicine.

There are also some reasons why a baby would not be able to join the study. These include if the baby is known to have serious heart problems or other life-threatening conditions. Babies would also not be part of the study if they already have a way for medicine to be given into their body, or if the medical team responsible for their care hasn't been specifically trained in the new umbilical cord procedure. Finally, if twins are born needing this help at the same time, only one would be able to participate.

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 full-term (born at 37 weeks or later)?
Does my baby need resuscitation right after birth?
Does my baby have a very slow heart rate or a stopped heart, needing adrenaline?
Does my baby NOT have known serious heart or other life-threatening problems?
Has the medical team been trained in the new study procedure?

Answer every question to see your result.

What does participation involve?

This study is focused on an emergency procedure; therefore, participation starts immediately. If a newborn meets the criteria for this urgent treatment, the new method of placing the umbilical vein catheter will be used. There are no additional visits or assessments required beyond the standard medical care your baby would receive. The study evaluates the safety and effectiveness of the procedure itself. Participation is integrated into the emergency medical care, and there will be no extra medication or follow-up specifically for the study, beyond what is medically necessary for your baby's treatment.

Potential risks and benefits

The potential benefit of this study is that it might show a quicker and safer way to give life-saving medicine to critically ill newborns. A faster method could potentially improve the chances of a better recovery for these babies. However, as with any medical procedure, there are potential risks, though the study aims to assess safety carefully. You always have the right to withdraw your baby from the study at any time, and this will not affect the quality of medical care your baby receives.

Locations (5)

Paediatric resuscitation and neonatal medicine department- Centre Hospitalier Universitaire Amiens-Picardie
Verified postcode
Amiens, France
Neonatal medicine department - Hôpital Louis Mourier
Verified postcode
Colombes, France
Neonatal medicine and resuscitation department - Centre hospitalier intercommunal de Poissy Saint-Germain-en-Laye - Poissy site
Verified postcode
Poissy, France
Neonatal medicine - neonatal resuscitation department - Hôpital Delafontaine
Verified postcode
Saint-Denis, France
Neonatal medicine and resuscitation department - Centre Hospitalier de Troyes
Verified postcode
Troyes, France

Common questions

What is an umbilical vein catheterisation?

It's when a small tube is put into a vein in a baby's umbilical cord to give medicines quickly, especially in emergencies.

Why is this new method being studied?

The study wants to see if a different technique to access the umbilical vein is quicker, safer, and more effective than the usual method for giving emergency medicines to newborns.

Will my baby get different care if they are in the study?

Your baby will receive necessary emergency care. The study is about using a potentially faster method for a standard life-saving procedure, not about withholding or changing essential treatment.

What does 'Wharton's jelly' mean?

Wharton's jelly is a protective, gel-like substance found inside the umbilical cord. The study explores if going through it directly is better.

Who is funding this research?

Information about funding is not provided in the summary, but research studies are often funded by government grants, medical charities, or pharmaceutical companies.

How to find out more

Maryline Delattre

maryline.delattre@ght-novo.fr +3333130754131 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.