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Enrolling by invitationOBSERVATIONAL

Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation?

This study is investigating if giving certain helpful germs, called probiotics, can lower the risk of a serious gut condition known as necrotising enterocolitis (NEC) in babies born very prematurely. NEC is a major concern for tiny babies, and this research aims to understand if probiotics make a difference. Researchers are looking back at health information already collected from babies born before 32 weeks of pregnancy in hospitals across England and Wales between 2016 and 2022. They will compare a large group of babies who received probiotics with a similar group who didn't, to see if there's a difference in how often NEC occurred. They will also compare two common types of probiotics.

At a glance

Status
Enrolling by invitation
Sponsor
Imperial College London
Enrolment target
48,000
Start
30 May 2024
Estimated completion
30 Dec 2026

What is this study about?

This study focuses on a serious health problem called necrotising enterocolitis (say: nek-roh-TY-sing en-ter-oh-koh-LY-tis), or NEC. NEC is a severe gut condition that can affect babies born very early, especially those born before 32 weeks of pregnancy. It's a major worry for doctors and parents because it can be life-threatening or cause long-term health problems for these vulnerable infants.

Researchers want to find out if giving 'probiotics' might help. Probiotics are special helpful bacteria, similar to those found in some yoghurts, that can improve gut health. The study aims to see if babies who received these probiotics were less likely to develop NEC compared to babies who didn't. They will also compare how well two different types of probiotics worked.

Instead of starting a new experiment, the researchers are using existing health records from a large number of babies born very early in hospitals across England and Wales. This allows them to look back at information collected over several years to understand if probiotics made a difference in preventing NEC. This kind of study helps doctors understand better ways to care for our tiniest babies.

Key takeaways

  • Researchers are studying a serious gut condition called NEC in premature babies.
  • The study looks at whether helpful bacteria (probiotics) can reduce the risk of NEC.
  • It uses existing health records from babies in English and Welsh hospitals.
  • No new patients or treatments are involved in this study.
  • The findings could help improve care for very premature babies in the future.

Who may be eligible?

This study is looking at information from babies who were born before 32 weeks of pregnancy. They needed to have received care in a hospital in England or Wales between 2016 and 2022 that shares its information with a national database.

The study will not include babies if some important details about their birth or health are missing from the records. It also won't include babies who died in the first two days after birth, or those born with a major health problem that was present from birth.

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. Was your baby born before 32 weeks of pregnancy?
  2. Was your baby cared for in an NHS hospital in England or Wales?
  3. Was your baby born between 2016 and 2022?
  4. Does your baby's medical record have complete information (no major missing dates)?
  5. Did your baby not have a major medical problem from birth?
  6. Did your baby survive the first two days after birth?
Answer every question to see your result.

What does participation involve?

You or your baby will not be directly involved in this study, and you won't need to do anything. This study uses health information that has already been collected from many babies, keeping their details private. Researchers are simply looking back at existing records to learn from past experiences.

Potential risks and benefits

Since this study only uses existing, anonymous health data, there are no direct risks or benefits to individuals or their babies. The potential benefits are for future babies and families, as the findings could help doctors decide if probiotics are helpful and safe for very premature infants, potentially leading to better care and fewer cases of NEC. You do not need to do anything to withdraw from this study as it does not involve new participation.

Locations (1)

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

Common questions

What is NEC?

NEC (Necrotising Enterocolitis) is a serious gut problem that mostly affects very premature babies, making their intestines inflamed and sometimes damaged.

What are probiotics?

Probiotics are helpful micro-organisms, often called 'good bacteria,' that can live in your gut and are thought to improve digestion and health.

Why are you looking at old records?

By looking at health records that have already been collected, researchers can study how many babies developed NEC and if probiotics made a difference without involving new patients.

Will my baby's information be private?

Yes, all health information used in this type of study is handled with strict privacy measures, meaning individual babies cannot be identified.

What will this study tell us?

This study hopes to provide clear evidence on whether giving probiotics to very premature babies helps reduce their risk of developing NEC.

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 "Do Probiotics Reduce The Risk Of Severe Necrotising Enteroco…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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