Transfer of prednisolone into human breast milk and plasma of breastfeeding children - A low intervention cohort study with biobanking of breast milk and plasma
This research wants to find out how much of a medicine called prednisolone, used by mothers for conditions like arthritis or inflammatory bowel disease, gets into their breast milk and then into their baby's bloodstream. Doctors want to check the levels of prednisolone in a baby's blood two hours after they've had breast milk. This milk would have been collected one hour after the mum took her dose. They will also measure the amount of prednisolone in the mum's blood and breast milk, and the baby's natural stress hormone (cortisol). This will help doctors understand if babies are getting the medicine and if it's affecting them. This study is for women aged 18 and over who are breastfeeding.
At a glance
What is this study about?
This study is looking at an important question for breastfeeding mothers who take a medicine called prednisolone. Prednisolone is a common drug used to treat many conditions where your body's immune system is overactive, such as types of arthritis (rheumatoid, psoriatic), Lupus, muscle inflammation (myositis), and inflammatory bowel disease.
The main goal of this study is to measure exactly how much prednisolone passes from a mother's blood into her breast milk, and then into her baby's blood. Researchers will check the baby's blood for prednisolone two hours after they've fed on milk that was produced by the mum about an hour after she took her medicine. This helps them understand if the baby is exposed to the medicine and if so, how much.
Researchers will also measure the levels of prednisolone in the mother's blood and breast milk. They'll also check a natural stress hormone called cortisol in the baby's blood. Cortisol levels can sometimes be affected by medicines like prednisolone. This research is crucial to help doctors give the best advice to breastfeeding mothers who need to take this important medication.
Key takeaways
- The study looks at prednisolone levels in mothers' milk and babies' blood.
- It aims to understand medicine transfer during breastfeeding.
- It's for breastfeeding mothers taking prednisolone for long-term conditions.
- Participation involves blood and milk samples, coordinated around a feed.
- Your contribution helps provide better advice for other mums.
- You can withdraw from the study at any time.
Who may be eligible?
This study is particularly for women who are 18 years old or older and are currently breastfeeding. You would be considered for this study if you are already taking prednisolone for a long-term health condition such as rheumatoid arthritis, lupus, myositis, psoriatic arthritis, or inflammatory bowel disease.
Your doctors will need to make sure you and your baby fit all the other requirements for the study to ensure it's safe and that the results will be clear and helpful. This means that, unfortunately, not everyone who takes prednisolone and breastfeeds will be able to join, as there may be other specific health factors for you or your baby that the researchers need to consider.
- Are you 18 years old or older?
- Are you currently breastfeeding?
- Are you taking prednisolone for a long-term condition (like arthritis or IBD)?
- Have you been diagnosed with rheumatoid arthritis, SLE, myositis, psoriatic arthritis, or inflammatory bowel disease?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will continue with your usual prednisolone treatment. The main part of your involvement will be centred around one specific time point. You would take your prednisolone dose as usual. One hour after you take your medicine, a small sample of your breast milk would be collected and a small blood sample might also be taken from you.
Soon after this, you would feed your baby with your breast milk. Two hours after your baby has fed, a small blood sample would be taken from your baby. This blood sample will be used to measure the level of prednisolone and cortisol in your baby's blood. This will likely involve a single visit to a clinic or hospital for these measurements, and the total duration covering these specific measurements would be a few hours on that day.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
Why is this study important?
It helps us understand if prednisolone, a common medicine, passes to babies through breast milk and how much, so doctors can give better advice to breastfeeding mothers.
What is prednisolone used for?
It's a medicine used for conditions like arthritis, lupus, and inflammatory bowel disease, where the body's immune system is overactive.
Will my baby get lots of extra medicine if I join?
No, you will simply continue your usual dose. The study is about measuring what exposure already happens with current practice.
Do I have to change my feeding schedule?
The study will involve coordinating a feed with your medicine dose and the milk collection, but it's built around your typical feeding routine.
What if I change my mind about taking part?
You can leave the study at any time without giving a reason, and it won't affect your or your baby's medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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