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For decades, caffeine has been a cornerstone of care for very premature babies, helping them breathe and reducing the risk of serious complications. Despite its widespread use around the world, clinicians still do not know what dose gives these vulnerable babies the best chance of survival and healthy development.
Now, a world-first international clinical trial aimed at determining the most effective dose of caffeine for very premature babies is set to begin in Australia’s coffee capital, Melbourne.
Led by Mercy Hospital for Women and the University of Melbourne, the BabyCCINO (Caffeine Citrate to Improve Neonatal Outcomes) trial will compare three caffeine citrate dosing regimens commonly used in neonatal units around the world. The findings are expected to inform future international treatment guidelines for very premature babies.
Professor Brett Manley, Professor of Neonatal Medicine and Director of Neonatal Research at Mercy Hospital for Women and Professor at the University of Melbourne will lead the trial and said that while it’s best known as a morning pick-me-up, caffeine is a vital medicine for our smallest and most vulnerable humans.
“The goal of the BabyCCINO trial is to set a global standard for caffeine dosing, so every very premature baby around the world gets the dose that gives them the best chance to survive and thrive,” Professor Manley said.
“Some of the babies we care for at Mercy Hospital for Women’s Neonatal Intensive Care Unit weigh less than 500 grams when they are born. To put that into perspective, that’s less than the weight of a typical block of chocolate. They are incredibly small, and their brains and lungs are still developing, so it’s very common for them to forget to breathe,”
Each pause in breathing, known as apnoea, can cause a baby’s oxygen levels and heart rate to drop, and frequent episodes put these fragile babies at greater risk of chronic lung disease and long-term developmental problems. Caffeine citrate reduces these pauses, helping babies come off breathing support sooner and protecting their developing lungs and brains.
The BabyCCINO trial will open on 14 October at Mercy Hospital for Women in Heidelberg with the study expected to enrol around 3,900 babies across Australia and New Zealand, making it the largest trial of caffeine dosing ever undertaken in premature babies.
Professor Manley said that neonatal care has evolved considerably since the standards were first set by the international Caffeine for Apnea of Prematurity (CAP) trial in 2006, and that it is time to carefully review which dosage is the most effective.
The CAP trial found caffeine reduced rates of chronic lung disease, and follow-up of the babies at 18 months showed those who received caffeine were more likely to survive without disability, including lower rates of cerebral palsy.
“Neonatal care has changed dramatically in the past 20 years. We’re now caring for babies born as early as 22 weeks, as opposed to 28 weeks when the original CAP trial was completed. BabyCCINO will help us find out what dose is right for the different weight ranges of babies we care for today,” Professor Manley said.
“The earlier a baby is born, the more risks they face. Getting their caffeine dose right is one simple step we can take to give them the best chance of thriving.”
The trial is funded by a $3,014,066 grant from the National Health and Medical Research Council, with a portion of a Medical Research Future Fund grant and philanthropic support from Running for Premature Babies.
More information about the trial can be found at: https://www.platipustrial.org/domains/babyccino
