RecruitingNAINTERVENTIONAL

Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula

This study aims to improve surgery for babies born with a condition where their food pipe isn't fully formed (oesophageal atresia) and is connected to their windpipe (distal tracheo-oesophageal fistula). Surgeons will use a special dye called Indocyanine Green (ICG) and a light called near-infrared fluorescence (NIRF) during the operation. We want to see if this dye can help predict or even prevent leaks at the surgical join of the food pipe, as these leaks can cause serious problems. The study will also look at how the dye temporarily affects some medical monitors, like oxygen readings. Ultimately, this research could lead to better outcomes for these babies.

At a glance

Status

Recruiting

Phase

Sponsor

Birmingham Women's and Children's NHS Foundation Trust

Enrolment target

Start

01 Mar 2023

Estimated completion

01 Mar 2026

Tracheo-Esophageal Fistula with Atresia of Esophagus

What is this study about?

This research is looking into a birth condition where a baby's food pipe (oesophagus) doesn't connect properly and sometimes has an abnormal link to their windpipe (trachea). This condition, called oesophageal atresia with distal tracheo-oesophageal fistula, requires surgery to join the food pipe together.

During this surgery, a common and serious complication can be a 'leak' at the point where the food pipe is joined. We want to see if using a special dye called Indocyanine Green (ICG), alongside a light called near-infrared fluorescence (NIRF), can help surgeons identify areas that are at higher risk of leaking. If we can predict these leaks, or even reduce them, it could make a big difference to how well babies recover and how long they need to stay in hospital. This dye has been used safely in adult operations for similar purposes.

The study also aims to understand how the ICG dye might temporarily affect some medical monitoring equipment that measures oxygen levels. It’s known that the dye can briefly interfere with these readings, rather than actually changing the baby's oxygen levels. Understanding these temporary effects will help doctors interpret the monitoring results accurately during and after surgery.

Key takeaways

Investigating a special dye (ICG) to improve surgery for babies.
Aims to predict or prevent leaks after food pipe repair.
Could lead to better outcomes and shorter hospital stays.
Looking at how the dye affects oxygen monitoring (temporarily).
Participation is voluntary and will not affect medical care.

Who may be eligible?

This study is for babies born with oesophageal atresia and a connection to their windpipe (distal tracheo-oesophageal fistula), who are going to have surgery to repair their food pipe. Our doctors will confirm the diagnosis and make sure surgical repair is suitable for your baby.

However, some babies cannot take part. This includes babies who weigh less than 2.5 kg, have severe heart problems, or are allergic to the ICG dye, iodine, or have an overactive thyroid. Babies with severe kidney disease or who need certain blood transfusions are also not eligible. If there are other concerns about giving the dye during anaesthesia, your baby would also not be able to participate. Most importantly, voluntary consent from parents is essential.

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 oesophageal atresia and a connection to the windpipe?
Is your baby scheduled for surgery to repair their food pipe?
Does your baby weigh at least 2.5 kg?
Does your baby have any known allergies to iodine or the ICG dye?
Does your baby have severe heart or kidney problems?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to take part, the special ICG dye would be given during their planned surgery. The research team would then observe how the dye shows up with a special light to assess the blood flow in the food pipe. They would also monitor how the dye temporarily affects some routine oxygen readings. No extra blood tests beyond what is already planned for the surgery would be taken. There are no additional hospital visits or follow-up appointments required solely for this study. The total duration of your baby's participation would be during their surgical procedure and immediate recovery period in hospital.

Potential risks and benefits

The main potential benefit of this study is advancing our understanding of how to reduce leaks after food pipe surgery in babies, which could lead to better surgical techniques and improved outcomes in the future. The risks associated with ICG dye are generally low but include the potential for temporary interference with some medical monitoring equipment, which the medical team is aware of and will account for. There's also a very small risk of allergic reaction to the dye. Participation in any clinical trial is entirely voluntary, and you are free to withdraw your consent and your baby from the study at any time without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Birmingham children's hospital
Verified postcode
Birmingham, United Kingdom· Recruiting

Common questions

What is oesophageal atresia?

It's a birth condition where a baby's food pipe (oesophagus) doesn't fully develop, often meaning it has a gap or an abnormal connection to the windpipe.

What is Indocyanine Green (ICG) and how is it used?

ICG is a special dye that's injected into the body. When a special light (NIRF) shines on it, it glows, allowing surgeons to see blood flow in tissues during an operation.

What are 'leaks' mentioned in the study?

After the food pipe is surgically joined, a 'leak' is when the join doesn't seal perfectly, allowing fluid to escape. This can cause complications.

Will this study change my baby's surgery?

The goal is to provide surgeons with more information during the operation to potentially make better decisions that reduce the risk of leaks, but the fundamental surgical approach remains the same.

Will my baby get extra tests or medicines because of this study?

Your baby will receive one additional medication (ICG dye) as part of the study. No extra blood tests will be taken beyond what's already planned for your baby's surgery and care.

How to find out more

max pachl

max.pachl@nhs.net 01213339999 Official trial record

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