RecruitingPHASE3INTERVENTIONAL

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

This study, called ESTHI, is investigating the best way to treat a condition called hydrocephalus, which is when there's too much fluid in a baby's brain. Traditionally, doctors have used a 'shunt' – a thin tube that drains the fluid away. A newer treatment is a keyhole surgery called ETV+CPC, which aims to help the brain manage the fluid itself without a shunt. Doctors want to understand if this new keyhole surgery helps intellectual development as much as the traditional shunt. The study will compare how well babies learn and develop, and also look at their brain structure. This information will help families and doctors decide the best treatment for babies with hydrocephalus.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Utah

Enrolment target

176

Start

21 Jul 2020

Estimated completion

31 Aug 2027

Hydrocephalus

What is this study about?

Hydrocephalus is a condition where there's a build-up of fluid in the brain. This mostly affects babies and can cause problems if not treated. For a long time, the main treatment has been to put in a special tube called a 'shunt'. This shunt helps drain the extra fluid from the brain to another part of the body, usually the tummy, where it can be absorbed naturally.

More recently, a different keyhole surgery, called Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC), has become available. This surgery doesn't involve putting in a permanent tube; instead, it's designed to help the brain manage the fluid on its own. The hope is that this might lead to fewer problems later on in a child's life compared to having a shunt.

However, doctors aren't yet sure if this newer keyhole surgery helps children's thinking and learning abilities as much as the traditional shunt. This study aims to compare these two treatments directly. By doing this, we hope to find out which treatment gives babies the best chance for healthy brain development and learning. The results will be really helpful for parents and doctors when deciding on the best care for babies with hydrocephalus.

Key takeaways

This study compares two hydrocephalus treatments in babies: shunt vs. keyhole surgery.
It aims to find out which treatment is best for brain development and learning.
Babies will be randomly assigned to receive one of the two treatments.
The study involves regular check-ups and special brain scans.
Your baby's medical care won't be affected if you withdraw from the study.

Who may be eligible?

This study is for babies under two years old (specifically, under 104 weeks of age) who were born at 37 weeks or later. They must have hydrocephalus that is causing symptoms. This means they have too much fluid in certain parts of their brain shown on an MRI scan, along with at least one additional sign like a very large head, a soft spot on their head that bulges, or unexplained sickness.

Babies unfortunately can't join the study if they've already had a shunt put in or had the ETV surgery before. Also, certain medical conditions might mean a baby isn't suitable, for example, if they have another serious illness, or if their brain or tummy isn't suitable for one of the procedures.

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 your baby less than two years old?
Was your baby born after 37 weeks of pregnancy?
Does your baby have hydrocephalus with symptoms?
Has your baby never had a shunt or ETV surgery before?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to take part, they will be randomly assigned to receive either the traditional shunt surgery or the newer ETV+CPC keyhole surgery. This is like flipping a coin to decide, making sure the study is fair. After the surgery, your baby will have regular check-ups with the study team. These visits will involve various assessments to see how they are developing, especially their thinking and learning skills. Doctors will also use special MRI scans to look at how their brain is developing. The study will last for a period after the surgery, and you'll be told exactly what to expect regarding appointments and tests.

Potential risks and benefits

Taking part in this study may offer benefits, such as receiving close monitoring and care from expert doctors. The results could also help future families make important treatment decisions. However, as with any medical procedure, both types of surgery carry potential risks, such as infection or the need for further operations. The study aims to understand these better. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (21)

Children's of Alabama
Verified postcode
Birmingham, United States· Recruiting
Phoenix Children's Hospital
Verified postcode
Phoenix, United States· Not yet recruiting
Children's Hospital of Los Angeles
Verified postcode
Los Angeles, United States· Recruiting
Children's Hospital Colorado
Verified postcode
Aurora, United States· Recruiting
Yale University
Verified postcode
New Haven, United States· Active not recruiting
Wolfson Children's Hospital
Verified postcode
Jacksonville, United States· Recruiting
Arnold Palmer Hospital for Children
Verified postcode
Orlando, United States· Recruiting
Trustees of Indiana University
Verified postcode
Indianapolis, United States· Not yet recruiting
Johns Hopkins Children's Center
Verified postcode
Baltimore, United States· Recruiting
St. Louis Children's Hospital
Verified postcode
St Louis, United States· Recruiting
Nationwide Children's Hospital
Verified postcode
Columbus, United States· Recruiting
Children's Hospital of Pittsburgh of UPMC
Verified postcode
Pittsburgh, United States· Recruiting

Common questions

What is hydrocephalus?

It's when there's too much fluid in a baby's brain, which can cause problems if not treated.

What's the difference between the two treatments?

One uses a tube (shunt) to drain fluid, and the other is a keyhole surgery (ETV+CPC) to help the brain manage the fluid itself.

Will my baby definitely get the new surgery if I join?

No, your baby will be randomly assigned to get one of the two treatments, like drawing lots.

What do you mean by 'intellectual outcome'?

This refers to how well a child's thinking, learning, and development progress over time.

Can I change my mind about my baby being in the study?

Yes, you can withdraw your baby from the study at any point without it affecting their medical care.

How to find out more

Nichol Nunn

nichol.nunn@hsc.utah.edu 801-458-6593 Official trial record

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