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Not yet recruitingOBSERVATIONAL

THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants

The B-BABIES study is looking into vitamin B12 levels in babies born early, specifically when they are ready to go home from the hospital. Babies born prematurely grow very quickly and need lots of nutrients, especially B vitamins like B12 and folate, for healthy development and making red blood cells. Researchers want to see how common a lack of vitamin B12 is in these babies, given current hospital feeding practices. They will also look at how diet (like breast milk) and how early a baby was born might affect their vitamin levels. This study helps ensure preterm babies get the best possible nutrition for a good start in life.

At a glance

Status
Not yet recruiting
Sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Enrolment target
40
Start
01 Sep 2025
Estimated completion
30 Sep 2026

What is this study about?

When babies are born early (prematurely), they have a lot of catching up to do, and their bodies grow incredibly fast. This rapid growth means they need plenty of essential nutrients. Two very important ones are vitamin B12 and folate, which are vital for healthy development and for making red blood cells. Babies born early might not have built up enough of these vitamins while in the womb, and their quick growth can use them up quickly.

During their time in the hospital, premature babies get their nutrition through special feeding methods, which often include these important vitamins. However, once they are preparing to go home, some of these special feeding supports might be reduced or stopped. We know that previous studies showed premature babies had good folate levels when leaving the hospital, but there haven't been recent studies looking at vitamin B12 levels. This study aims to fill that gap and understand how common low vitamin B12 levels might be in these babies.

By carefully checking the vitamin B12 levels in premature babies when they are discharged, this study will help doctors and nutritionists understand if the current feeding guidelines are providing enough of this crucial vitamin. It will also look at whether different factors, like being fed only breast milk or being born extremely early, affect these vitamin levels. This research ultimately helps make sure that all premature babies receive the best possible nutritional care for their healthy growth and development.

Key takeaways

  • The study looks at vitamin B12 levels in babies born early.
  • It helps understand if current feeding methods support healthy development.
  • No new treatments are given; it's an 'observational' study.
  • Information from routine hospital care is used.
  • Results could improve nutrition for future premature babies.

Who may be eligible?

This study is looking for babies who were born early, specifically those born before 37 weeks of pregnancy. They also need to have been admitted to one of the hospitals taking part in the study and be able to drink milk (either from a bottle, breast, or feeding tube) without issues.

Babies would not be able to join the study if they have known or suspected problems with their genes, metabolism, or major birth defects. Also, if a baby has certain other health conditions that would make it difficult to follow standard feeding plans, or if their condition might affect the study results (like kidney problems or an underactive thyroid), they would not be eligible.

The study includes babies of all genders and is for those aged from birth up to 28 days old.

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 37 weeks of pregnancy?
  2. Is your baby currently an inpatient at the study hospital?
  3. Can your baby take milk feeds (breast, bottle, or tube)?
  4. Does your baby have any known genetic problems or major birth defects?
  5. Does your baby have a health condition that changes standard feeding or might affect test results (like kidney disease)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, your baby will be included in an 'observational' study. This means the researchers will simply observe and collect information about your baby's vitamin B12 levels based on their current hospital care and feeding. There are no new medications or treatments given as part of this study. The researchers will mostly use information and samples (like blood samples) that are already being collected for your baby's routine medical care. They will also look at your baby's diet and possibly take a small sample of your breast milk if you are breastfeeding. The total duration of your baby's participation will be during their hospital stay, specifically when they are getting ready for discharge.

Potential risks and benefits

Taking part in this study doesn't involve any extra medical procedures beyond what your baby would normally receive in the hospital. The main benefit is that the information gathered will help improve our understanding of nutrition for premature babies, potentially leading to better care for future infants. There are no direct benefits to your baby, and there are no additional risks beyond those associated with routine hospital care. You are free to withdraw your consent and your baby from the study at any time, without it affecting your baby's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Norfolk and Norwich University Hospital NHS Foundation Trust
    Verified postcode
    Norwich, United Kingdom

Common questions

What is vitamin B12?

Vitamin B12 is a very important nutrient that helps your baby's body make red blood cells and keeps their nervous system healthy. It's crucial for their rapid growth and development.

What does 'preterm' mean?

'Preterm' means a baby was born early, before 37 full weeks of pregnancy. These babies often need special care to help them grow and develop.

Will my baby get extra tests or treatments if we join?

No, your baby won't receive any extra tests or different treatments just for this study. The researchers will mostly use information that's already part of your baby's regular hospital care.

Why are you studying vitamin B12 in preterm babies?

Babies born early grow very quickly, and we want to make sure they are getting enough vital nutrients like vitamin B12 for their healthy development, especially when they are preparing to go home.

Who is running this study?

This study is being run by researchers and medical staff at a Neonatal Intensive Care Unit (NICU) in one hospital.

How to find out more

Dr Isabel Iglesias-Platas

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 B-BABIES STUDY: An Observational Study of Group B Vitami…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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