RecruitingNAINTERVENTIONAL

Prospective Evaluation of OptiThyDose

This study is looking into a new way for doctors to work out the best medicine dose for children with thyroid diseases. It focuses on two conditions: Congenital Hypothyroidism, which babies are born with, and Graves' Disease, which can develop in childhood. Proper treatment for thyroid problems in children is very important for their brain development, growth, and overall health. Finding the right dose can be tricky, so researchers have created 'OptiThyDose', a new computer model. This study aims to see how well OptiThyDose helps doctors give accurate medicine doses, hoping to lead to fewer side effects and better results for children with these conditions.

At a glance

Status

Recruiting

Phase

Sponsor

University Children's Hospital Basel

Enrolment target

150

Start

28 Aug 2025

Estimated completion

01 Feb 2029

Thyroid Diseases Congenital Hypothyroidism Graves Disease

What is this study about?

Thyroid diseases can affect people from birth right through to adulthood. Some babies are born with a thyroid problem, which is called Congenital Hypothyroidism, while others, like Graves' Disease, can develop later in childhood. Treating these conditions quickly and correctly is really important because the thyroid gland plays a big part in many body functions, including brain development, growth, and how a child learns and thinks. If these conditions aren't treated well, they can cause long-term problems.

However, giving the right amount of medicine to children can be difficult. Too little medicine won't help, but too much can also cause problems. Doctors need a way to find a balance, especially as more children around the world are being diagnosed with thyroid conditions.

This is where OptiThyDose comes in. It's a new mathematical model – like a special computer program – that has been designed to help doctors work out the most accurate and individualised dose of thyroid medicine for each child. The main goal of this study is to test how well OptiThyDose performs in helping children with Congenital Hypothyroidism and Graves' Disease get the right amount of medication.

Key takeaways

The study aims to improve how thyroid medication is dosed for children.
It focuses on two conditions: Congenital Hypothyroidism and Graves' Disease.
A new tool, OptiThyDose, is being tested to find the best individual medicine dose.
Accurate dosing helps prevent long-term health issues in children.
The study includes children up to 18 years old.

Who may be eligible?

This study is looking for children aged up to 18 years old to take part. For babies with Congenital Hypothyroidism, they will need to have had an abnormal screening test after birth and a blood test that shows high thyroid-stimulating hormone (TSH) levels.

For children with Graves' Disease, they can be newly diagnosed, experiencing the condition again after treatment, or have Graves' Disease that isn't well controlled with their current medication. Their blood tests would show low TSH, high thyroid hormones, and positive antibodies linked to Graves' Disease. They might also have typical signs like a swollen neck (goitre), a fast heartbeat, weight loss, or changes in mood.

There are also some reasons why a child might not be able to join the study. For example, newborns whose mothers have Graves' Disease are not included, nor are patients experiencing a life-threatening health event. Children with Graves' Disease will also be excluded if their hyperthyroidism is caused by other specific, rare conditions that are not Graves' Disease.

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 child 18 years old or younger?
If my child has Congenital Hypothyroidism, were they diagnosed as a newborn with high TSH levels?
If my child has Graves' Disease, have they been recently diagnosed, or is their condition recurring or not well controlled?
Is my child able to attend regular appointments for the study?
Does my child not have any other specific, rare causes for hyperthyroidism?
Has my child not had a life-threatening event recently?

Answer every question to see your result.

What does participation involve?

The information provided in the summary is too brief to confirm what participation would involve regarding visits, assessments, medication, follow-up, or total duration. Generally, in studies like this, participants would likely have regular doctor's visits, blood tests to check their hormone levels, and monitoring of their overall health. They would receive medicine as part of their standard care, and the study would observe how the OptiThyDose tool helps guide their treatment. The full details of exact procedures, the number of visits, and how long the study lasts would be explained by the study team if you consider taking part.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving careful and individualised dosing of thyroid medication guided by the new OptiThyDose tool, which could lead to better health outcomes and fewer side effects. There are always potential risks in any medical study, though this study appears to focus on refining treatment dosing rather than testing new medications. Any potential risks specific to taking part would be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your child's standard medical care.

Locations (2)

Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris
Verified postcode
Paris, France· Not yet recruiting
Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB)
Verified postcode
Basel, Switzerland· Recruiting

Common questions

What is the 'thyroid' and why is it important?

The thyroid is a small gland in your neck that makes hormones. These hormones control how your body uses energy and are vital for growth and brain development, especially in children.

What is 'Congenital Hypothyroidism'?

This is a condition where a baby is born with an underactive thyroid gland, meaning it doesn't make enough thyroid hormone. It's usually picked up by a routine test shortly after birth.

What is 'Graves' Disease'?

Graves' Disease is a condition where the thyroid gland is overactive, making too much thyroid hormone. This can cause symptoms like a fast heartbeat, weight loss, and feeling restless.

What is 'OptiThyDose'?

OptiThyDose is a new computer-based tool or method designed to help doctors work out the most accurate and personalised dose of thyroid medicine for children.

Will taking part in this study cost me anything?

Generally, clinical trials cover the costs related to the study itself. You should confirm with the study team whether there are any costs you might need to cover, such as travel to appointments.

How to find out more

Gabor Szinnai, Prof. MD, PhD

gabor.szinnai@ukbb.ch +41 61 704 29 22 Official trial record

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