RecruitingNAINTERVENTIONAL

Intact Cord Resuscitation in CDH

This study is investigating a rare condition called Congenital Diaphragmatic Hernia (CDH), where a baby's diaphragm doesn't form properly, allowing organs to move into the chest. This is a serious condition, with varying outcomes. Researchers are comparing two ways of managing the umbilical cord at birth for babies with CDH. One group will have the cord clamped immediately, as is standard practice. The other group will have 'intact cord resuscitation,' meaning the cord stays attached for a short time while medical support is given to the baby. The aim is to see if keeping the cord intact helps these babies adapt better to breathing and life outside the womb. This is a multi-centre study, meaning it's happening in different hospitals.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Lille

Enrolment target

180

Start

08 Oct 2020

Estimated completion

01 Oct 2026

Rare Diseases Congenital Diaphragmatic Hernia

What is this study about?

Congenital Diaphragmatic Hernia (CDH) is a rare condition that affects about 1 in 3,500 babies. It happens when a baby's diaphragm, the muscle that helps us breathe, doesn't close properly during pregnancy. This can allow organs from the tummy, like the stomach or liver, to move up into the chest cavity. This can stop the lungs from developing as they should, making it difficult for the baby to breathe after birth. The seriousness of CDH can vary a lot from one baby to another, and sadly, between 20% and 50% of babies with CDH don't survive, depending on the hospital and how they are cared for.

Doctors are always looking for better ways to help babies with CDH. Studies have already shown that waiting a little longer to clamp the umbilical cord after birth can be good for many newborns, helping them adapt better to breathing on their own and getting enough blood. Some early research also suggests this might be helpful for babies with CDH.

This study wants to find out if keeping the umbilical cord attached for a short time, while doctors and nurses help the baby with their first breaths and other medical care (this is called 'intact cord resuscitation'), is better than clamping the cord straight away. They want to see if it helps babies with CDH adapt better to life outside the womb, particularly with their breathing and heart function. This research is comparing these two approaches to see if one makes a real difference for these vulnerable babies.

Key takeaways

Study looks at managing the umbilical cord for babies with CDH.
Compares immediate clamping vs. keeping cord intact for a short time.
Aims to improve breathing and heart adaptation at birth.
Only full-term babies (over 36 weeks) with isolated CDH can participate.
No new medications are involved in this study.

Who may be eligible?

To join this study, a baby must have been diagnosed with CDH during pregnancy and be born full-term, meaning after 36 weeks of pregnancy. They shouldn't have any other serious health problems or genetic conditions, and they shouldn't be part of another research study during the pregnancy.

Babies cannot join the study if they are born before 37 weeks of pregnancy, have other major health issues or genetic conditions, or are a twin. Parents need to give their written consent to their baby taking part. If parents have difficulty understanding French, the study team will provide help to make sure they fully understand what they are agreeing to.

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.

Has your baby been diagnosed with CDH during pregnancy?
Is your baby expected to be born full-term (after 36 weeks)?
Does your baby not have other serious medical conditions or genetic problems?
Are you able to give written consent for your baby to take part?

Answer every question to see your result.

What does participation involve?

This study focuses on what happens around the time of birth. If your baby is eligible and you agree for them to take part, they will be randomly assigned to one of two groups. One group will have their umbilical cord clamped immediately after birth, as is standard care. The other group will have 'intact cord resuscitation,' where the cord remains attached for a short period while medical staff provide help to your baby, such as assistance with breathing.

Researchers will then closely monitor your baby's breathing and heart function immediately after birth to see how they adapt. This study doesn't involve any new medications, but rather a different approach to managing the umbilical cord. There are no extra hospital visits or long-term follow-ups required specifically for this study beyond your baby's usual medical care.

Potential risks and benefits

The potential benefit of taking part is that intact cord resuscitation might help your baby adapt better to life outside the womb, especially with their breathing and heart function. However, it's also possible that there will be no difference between the two approaches, or that the immediate clamping method might be better for some babies. There aren't many known risks to either method when performed by medical professionals. You have the right to withdraw your consent for your baby to participate at any time, without it affecting your baby's medical care.

Locations (3)

Chu Amiens Picardie
Verified postcode
Amiens, France· Recruiting
Hop Jeanne de Flandre Chu Lille
Verified postcode
Lille, France· Recruiting
Chu de Nantes -
Verified postcode
Nantes, France· Recruiting

Common questions

What is CDH?

CDH (Congenital Diaphragmatic Hernia) is a rare condition where a baby's diaphragm, the breathing muscle, doesn't form properly, causing organs to move into the chest.

Why are you studying the umbilical cord?

We want to see if keeping the umbilical cord attached for a short time after birth helps babies with CDH adapt better to breathing and life outside the womb.

Will my baby get any new medicines?

No, this study doesn't involve any new medicines. It's about how the umbilical cord is managed right after birth.

Who can take part in this study?

Babies with CDH diagnosed before birth, born full-term (after 36 weeks), and without other serious conditions can potentially join.

Can I change my mind about my baby taking part?

Yes, you can withdraw your consent for your baby to be in the study at any time without affecting their medical care.

How to find out more

Laurent Storme, MD,PhD

laurent.storme@chru-lille.fr 03 20 44 61 99 Official trial record

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