Active not recruitingOBSERVATIONAL

Improving Infant Hydrocephalus Outcomes in Uganda

This study in Uganda is for babies under six months old who have hydrocephalus. This condition means there's too much fluid in the brain. Often, doctors use a tube called a shunt to drain this fluid, but shunts often need more operations over a person's life. This research is looking at a different surgical option called ETV/CPC, which aims to help babies live without needing a shunt. Researchers want to understand exactly how well this new treatment works and identify better ways to predict if it will be successful. By improving how we treat hydrocephalus, the study hopes to make a big difference for many young babies in Uganda.

At a glance

Status

Active not recruiting

Sponsor

Boston Children's Hospital

Enrolment target

400

Start

05 May 2021

Estimated completion

01 Dec 2027

Hydrocephalus

What is this study about?

This study is focused on a serious condition called hydrocephalus, which means there's a build-up of fluid in a baby's brain. This can cause problems with growth and development. In East Africa, this can often happen after infections in babies, which is why it's a big health concern there.

For many years, the main way to treat hydrocephalus has been to put a special tube, called a shunt, into the brain. This shunt helps drain the extra fluid away. However, these shunts often need regular checks and can stop working, meaning a child might need many operations throughout their life. This study is exploring a different operation called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (CPC), often just called ETV/CPC.

The main goal of this study is to see how well ETV/CPC works, particularly in very young babies. Researchers want to find better ways to measure if the treatment is successful and how it affects babies in the long run. By doing this, they hope to improve the lives of babies with hydrocephalus, giving them a chance to grow up without needing a shunt.

Key takeaways

This study is for babies under 6 months with hydrocephalus in Uganda.
It compares traditional shunt surgery with a new surgery (ETV/CPC).
The goal is to help babies avoid lifelong shunt problems.
Researchers want to understand how well the new treatment works long-term.
Only babies from specific Ugandan districts near CURE hospital can participate.

Who may be eligible?

To be considered for this study, babies must be less than six months old. They should have clear signs of hydrocephalus, meaning their head is growing too fast, a soft spot on their head is bulging, and scans show extra fluid in their brain.

Parents or legal guardians in Uganda must be able to give permission for their baby to join the study. Only babies from certain areas of Uganda, specifically the Eastern, Central, and Northern districts near CURE hospital, can take part.

Babies who are older than six months, don't show clear signs of hydrocephalus, or live outside the specific districts mentioned won't be able to join this study.

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 less than 6 months old?
Does my baby have signs of hydrocephalus (e.g., fast head growth, bulging soft spot)?
Do I, as a parent or guardian, have legal permission to agree to medical care in Uganda?
Do we live in Eastern, Central, or Northern Uganda, close to CURE hospital?

Answer every question to see your result.

What does participation involve?

The information provided does not fully detail the specifics of what taking part would involve in terms of visits, assessments, or overall duration. However, generally, if your baby were to join this study, they would likely undergo one of the two surgical procedures being compared for hydrocephalus treatment (either the standard shunt placement or the ETV/CPC procedure). There would be follow-up appointments to monitor their recovery and the effectiveness of the treatment. These would involve regular check-ups with doctors and potentially scans to see how the fluid in the brain is managed after the operation. You would be given instructions on how to care for your baby after surgery and when to attend follow-up appointments.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For your baby, a potential benefit could be access to a treatment that aims to avoid the need for a lifelong shunt, which could mean fewer operations in the future. However, as with any surgery, there are risks involved such, as infection or other complications. The doctors will explain all potential risks and benefits in detail. Remember, choosing to join is completely up to you, and you can change your mind and withdraw your baby from the study at any time, for any reason, without it affecting your child's care.

Locations (3)

Penn State University
Verified postcode
University Park, United States
The Hospital for Sick Children
Verified postcode
Toronto, Canada
Cure Children's Hospital of Uganda
Verified postcode
Mbale, Uganda

Common questions

What is hydrocephalus?

Hydrocephalus is when there's too much fluid in a baby's brain, which can cause swelling and pressure.

What is a shunt?

A shunt is a small tube doctors can put into the brain to drain away extra fluid, but it often needs further operations.

What is ETV/CPC?

ETV/CPC is a different type of surgery that aims to help the brain manage its own fluid, potentially avoiding the need for a shunt.

Who can join this study?

Only babies under six months old with hydrocephalus from specific regions of Uganda can be considered for this study.

Can I change my mind after joining?

Yes, you can choose to withdraw your baby from the study at any time, and it won't affect their medical care.