Newborn babies, especially those born preterm, are a unique and vulnerable group with distinct medical needs. Yet, up to 90% of medications used in their care are prescribed off-label, meaning they haven’t been specifically tested for newborns. This can lead to challenges, such as unknown dosages, unexpected side effects, or treatments that aren’t as effective as they could be.

Clinical trials tailored to newborns are vital to change this. These studies ensure treatments are safe, effective, and specifically designed to meet the needs of babies, considering factors like gestational age, health conditions, and risk factors. By conducting ethical and carefully designed research, we can improve treatment outcomes, reduce side effects, and address unmet medical needs.

Discover more in our factsheet on clinical trials in newborns, available in English and French, and learn how research is shaping a healthier future for the tiniest patients.