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The Experience of Screening for SCID

This study is investigating a new screening test for Severe Combined Immunodeficiency (SCID), a rare but serious condition, in newborn babies. The test is done using the same blood spot already taken from babies at five days old. Researchers want to see how this new screening affects families and healthcare professionals. They will follow families from when their baby is screened until they are five years old. They will also talk to doctors and nurses involved in caring for these babies. The aim is to understand the real-world experiences and help decide if this screening should be offered to all babies in the UK, making sure it's the best approach for everyone involved.

At a glance

Status
Recruiting
Sponsor
King's College London
Enrolment target
90
Start
09 Nov 2022
Estimated completion
31 Mar 2029

What is this study about?

This project is all about a new blood test for babies to check for a rare but serious condition called Severe Combined Immunodeficiency, or SCID. It's sometimes called 'bubble baby disease' because children with SCID can't fight off germs and need special protection.

Currently, many babies around the world are screened for SCID, and experts think it might be a good idea to do this in the UK too. This study is a trial to see how this screening works in practice. Around two-thirds of babies born in England between September 2021 and August 2023 will be included. This means about 800,000 newborns will have this extra check.

The screening is done using the tiny blood sample already taken from babies' heels at five days old. If the test suggests a baby might be at higher risk for SCID, parents will be told quickly and given an appointment to see a specialist the very next day. This specialist will do another blood test to get a clearer picture. Depending on these results, some babies will be given the all-clear, while others might need more careful checks or treatment. The study also wants to understand the experiences of both families and the healthcare teams involved in this process.

Key takeaways

  • This study is about a new blood test for babies to check for SCID.
  • It uses a sample already taken at 5 days old (heel prick).
  • It aims to understand experiences of families and healthcare staff.
  • A 'positive' result means more tests, not necessarily SCID.
  • Findings could help decide if this screening should be routine for all UK babies.
  • Participation helps improve newborn care in the UK.

Who may be eligible?

To take part in this research, you need to be at least 18 years old. It's really important that you understand why the study is happening and what your involvement would mean.

If English isn't your first language, don't worry – the research team will arrange for a translator to help you understand everything clearly.

If, sadly, a child involved in the study passes away, the research team will gently ask the parents if they still wish to share their experiences. This helps them ensure that all perspectives are included, even in difficult circumstances.

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. Are you at least 18 years old?
  2. Do you understand what doing the study involves?
  3. Are you comfortable sharing your experiences about the screening process?
  4. Is your baby born in England between September 2021 and August 2023?
Answer every question to see your result.

What does participation involve?

If you agree to take part, the study will involve different steps. For families, this means researchers will follow your child's journey from when the screening results come back until they turn five years old. This will likely involve sharing your experiences and feelings about the screening process and your child's health over time. For healthcare professionals, the study will involve interviews where you can share your thoughts and experiences about introducing the new SCID screening programme.

The screening itself uses a tiny blood spot taken from your baby's heel at 5 days old, which is a standard procedure. If your baby's screen result suggests a higher risk, you'll be contacted quickly, and an appointment will be made for you to see an immunologist the next day. Another blood test will be done at this appointment, and results are usually available the same day. The length of your involvement in the study will depend on whether you are a family or a healthcare professional, with families being followed for up to five years.

Potential risks and benefits

Taking part in this study could help future families by showing whether SCID screening should be offered more widely, potentially leading to earlier treatment for children with SCID. While the blood test itself is routine and very safe, finding out a baby might be at risk, even if it's a false alarm, can be very stressful for parents. There's also a chance to find other immune problems that aren't SCID, and while this helps children, it can also create worry. You are free to withdraw from the study at any time without giving a reason, and this will not affect your child's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • King's College London
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is SCID?

SCID (Severe Combined Immunodeficiency) is a rare inherited condition where a baby's immune system isn't able to fight off serious infections.

How is this test done?

The test uses the same tiny blood sample taken from your baby's heel at 5 days old as part of the routine newborn screening. No extra blood is needed.

What if my baby has a 'positive' result?

A 'positive' result means your baby might be at higher risk. You would be contacted quickly and see a specialist the next day for more tests to confirm or rule out SCID or other immune problems.

Will my child definitely have SCID if the screen is positive?

No, a positive screen doesn't mean your child definitely has SCID. Many babies with a 'positive' result turn out to be healthy. The follow-up tests are crucial to find out for sure.

Who is involved in the study?

The study involves new parents whose babies are part of the screening trial and also doctors and nurses who care for babies with immune problems.

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 Experience of Screening for SCID…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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