All studies
RecruitingOBSERVATIONAL

The Dirty Nappy Study

The 'Dirty Nappy Study' is looking into whether a special computer program, called a machine-learning algorithm, can accurately find liver conditions in newborns like cholestasis and biliary atresia. Cholestasis means bile isn't flowing properly from the liver, which can cause damage. Biliary atresia is a more serious form where bile ducts are missing or damaged, needing quick treatment to prevent long-term health issues. The study wants to see if parents taking pictures of their baby's dirty nappies with a smartphone can help detect these conditions early. Researchers will compare images from babies with and without these conditions to see how well the computer program works. They also want to know if this method is easy and acceptable for parents to use.

At a glance

Status
Recruiting
Sponsor
Birmingham Women's and Children's NHS Foundation Trust
Enrolment target
5,350
Start
01 Apr 2025
Estimated completion
30 Sep 2026

What is this study about?

This study, called 'The Dirty Nappy Study', is looking for new ways to spot certain liver problems in newborn babies as early as possible. These problems, called cholestasis and biliary atresia, happen when bile, a fluid made by the liver, doesn't flow out properly. If bile builds up, it can harm the liver. Biliary atresia is a more serious condition where the small tubes that carry bile (called bile ducts) are damaged or missing from birth. It's really important to find these conditions quickly, especially biliary atresia, because early treatment can make a big difference to a baby's long-term health.

The researchers are using a special computer program, often called a machine-learning algorithm, that can learn to recognise patterns. They want to see if this program can accurately tell if a baby has cholestasis or biliary atresia by looking at pictures of their dirty nappies. The colour and consistency of a baby's poo can sometimes be an early sign of these liver conditions. The study will look at pictures from both healthy babies and those who have been diagnosed with these conditions to teach the computer program what to look for. They also want to find out if it's practical and easy for parents to take and send these pictures.

Ultimately, if this method works well, it could mean that more babies with these conditions are picked up earlier. This early detection could allow doctors to start treatment sooner, which might help prevent serious liver damage and improve the child's health in the long run. The study is comparing images from babies who have been diagnosed with these conditions to those who haven't, to make sure the computer program is accurate.

Key takeaways

  • The study aims to detect serious liver problems in babies early using smartphone photos of dirty nappies.
  • It uses a special computer program to analyse the nappy photos.
  • Early detection of conditions like biliary atresia can greatly improve a baby's health.
  • Parents take photos at 14, 21, and 28 days after birth.
  • Participation involves no hospital visits or medication for your baby.
  • You can withdraw your baby from the study at any time.

Who may be eligible?

This study is looking for different groups of babies to take part. For the main part of the study, they are inviting parents of healthy newborn babies (under 28 days old) who were born at one of the participating UK hospitals to join. They are also looking at babies who have been referred to the Birmingham Liver Unit because doctors suspect they might have cholestasis. This includes babies referred in the past 10 years and new referrals after the study started, as long as they were under 6 months old at the time of referral.

To join, a parent or guardian must be able to understand written English and give their clear permission for their baby to take part. There are no other special rules that would stop a baby from being included if they meet these basic requirements.

The study welcomes all babies, regardless of when they were born (full-term or premature) or their sex.

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.

  1. Is my baby less than 28 days old and born at a participating hospital (for healthy babies)?
  2. Has my baby been referred to Birmingham Liver Unit for suspected cholestasis (if that applies)?
  3. Am I, as the parent/guardian, able to understand written English?
  4. Am I willing to give permission for my baby to take part?
Answer every question to see your result.

What does participation involve?

If your baby takes part in the main part of the study, you'll be asked to take photos of their dirty nappies at certain times. You'll need to use your smartphone to snap pictures of your baby's poo when they are 14, 21, and 28 days old. After taking the photos, you'll upload them for the special computer program to look at. You'll also be asked to share your thoughts on how easy or difficult it was to take part in this screening process. There are no clinic visits specifically for this study, and no medication is involved. The main part of your involvement will last for the first month of your baby's life. Other parts of the study use existing medical records and images.

Potential risks and benefits

Taking part in this study involves very little risk for your baby, as it only requires you to take photos of their nappies. There are no medical procedures or medications involved. For your baby, the main benefit is that your participation helps scientists develop a new way to potentially detect serious liver conditions earlier in the future, which could improve outcomes for other babies. For you as a parent, there is the potential benefit of contributing to important medical research. You are free to withdraw your baby from the study at any time without giving a reason, and this will not affect your baby's medical care in any way.

Locations (1)

  • Birmingham Women's and Children's NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom· Recruiting

Common questions

What is cholestasis?

Cholestasis is a liver condition where bile, a fluid from the liver, doesn't flow out properly. This can cause it to build up in the liver, potentially leading to damage.

What is biliary atresia?

Biliary atresia is a more serious type of cholestasis where the bile ducts (small tubes carrying bile) are damaged or missing. It usually needs treatment early in a baby's life.

What does a 'machine-learning algorithm' do?

It's a computer program that learns from information. In this study, it's learning to spot signs of liver problems by looking at pictures of baby poo.

Do I need to visit a hospital for this study?

No, for the part of the study involving new parents, you won't need to visit the hospital extra. You'll take photos at home and upload them.

Will my baby get any medicine from this study?

No, this study does not involve giving any medication to your baby or any medical treatments.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "The Dirty Nappy Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.