Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support
This study is testing if it's possible to do a bigger research project on giving caffeine to premature babies who need help with their breathing. These babies are born between 28 and 34 weeks of pregnancy. The main goal is to see if caffeine helps them get well enough to go home from the hospital sooner. Researchers will also check if they can successfully enrol enough families and if the medical team follows the study plan correctly. Babies in the study will randomly receive either caffeine or a 'dummy' medicine (placebo) every day for as long as they need breathing support. The team will watch their progress, like how well they feed, their breathing, and how they grow, until they leave the hospital.
At a glance
What is this study about?
Imagine your baby is born quite early, between 28 and 34 weeks of pregnancy, and needs some help with their breathing. Doctors often give caffeine to very premature babies, but we don't fully understand how it helps those born a little later, who still need breathing support. This study is a first step to find out more. It's called a 'pilot' study, which means it's like a practice run to make sure a much bigger and more detailed study can be done properly in the future.
The main aim of this pilot study is to see if it's practical to carry out a larger trial. Can enough families be found and kept in the study? Do the nurses and doctors follow the instructions for giving the medicine correctly? It will also gently explore whether caffeine might help these babies need less time in the special care baby unit (NICU) before they can go home. The researchers will compare caffeine to a 'placebo', which looks exactly like the medicine but doesn't contain any active ingredient, to truly see if caffeine makes a difference.
Ultimately, if this pilot study goes well, it could lead to a bigger study that helps us understand if caffeine should be part of the standard care for these premature babies, potentially helping them grow stronger and get home to their families sooner.
Key takeaways
- This study explores if caffeine helps premature babies (28-34 weeks) with breathing problems.
- It aims to see if a bigger study on caffeine for these babies is practical.
- Babies will randomly receive either caffeine or a dummy medicine.
- The goal is to see if caffeine helps babies leave the hospital sooner.
- Participation is voluntary, and care won't be affected if you withdraw.
Who may be eligible?
Your baby might be able to take part in this study if they were born quite early, specifically between 28 and 34 weeks of pregnancy. They would also need to have been admitted to the special care baby unit (NICU) within the first three days of life and require some help with their breathing, either from a machine or with oxygen.
There are some reasons why a baby would not be able to join the study. For example, if they have certain serious birth defects or a known heart problem that causes their skin to turn blue. Babies born very, very early (before 28 weeks) often get caffeine routinely, so they wouldn't be part of this specific study. Also, babies born almost full-term (35 weeks or later) are usually not included because their stay in the NICU is typically shorter.
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.
- Was your baby born between 28 and 34 weeks of pregnancy?
- Did your baby need breathing support (like a machine or oxygen) within 3 days of birth?
- Does your baby not have certain severe birth defects or serious heart conditions?
- Is your baby not born extremely early (before 28 weeks) or nearly full-term (35 weeks or later)?
What does participation involve?
If your baby takes part, they will be put into one of two groups by chance, like flipping a coin. One group will receive caffeine, and the other will receive a 'placebo' (a dummy medicine with no active ingredients). You won't know which one your baby is getting, and neither will the healthcare team, as this helps make the results fair.
The study medicine will be given once a day, either through a drip into their vein or a feeding tube. Your baby will receive this treatment for as long as they need help with their breathing, and for an extra 24 hours after they no longer need that support. The study team will closely monitor your baby's progress, including how well they feed, how stable their breathing is, and how they are growing, until they are well enough to leave the hospital. There are no extra visits or tests specifically for this study; all monitoring will be part of your baby's usual care.
Potential risks and benefits
Locations (1)
- Kingston Health Science CenterVerified postcodeKingston, Canada
Common questions
What is a 'preterm birth'?
A preterm birth is when a baby is born before 37 full weeks of pregnancy. This study focuses on babies born between 28 and 34 weeks.
What is a 'placebo'?
A placebo is a substance that looks exactly like the real medicine but does not contain any active drug. It helps researchers compare the effects of the active medicine fairly.
Why don't we already know if caffeine helps these babies?
While caffeine is often used for extremely premature babies, there hasn't been enough research specifically on babies born between 28 and 34 weeks who need breathing support. This study aims to fill that gap.
Will my baby have extra needles or tests for the study?
No, your baby will not have any extra needles or tests. The study will use information gathered as part of your baby's normal hospital care.
Who pays for the caffeine or dummy medicine?
The study pays for the caffeine or placebo. You will not have to pay anything extra for your baby to participate in this research.
How to find out more
Eyad Bitar, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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