Newborns are at a high risk of developing serious infections, and the standard treatment is often intravenous (IV) antibiotics. However, this method poses significant downsides, including longer hospital stays and potential IV-related complications and side effects. It also disrupts critical periods of breastfeeding and parental bonding.
Andrew Haynes, MD, a pediatrician specializing in infectious diseases at Children’s Hospital Colorado, saw this as a barrier to providing optimal care for his youngest patients. He believes oral antibiotics could be a better alternative in many cases, but safe and effective doses for infants under 60 days old have not yet been established.
“Clinicians are often hesitant to give oral antibiotics to very young babies because of uncertainty about how they’re absorbed. As a result, many serious infections in the first few weeks of life are treated with prolonged IV antibiotics by default,” said Haynes, who is an assistant professor of pediatric infectious diseases in the University of Colorado School of Medicine. Through his research at the Colorado Clinical and Translational Sciences Institute (CCTSI), he hopes to establish dosing guidelines that will help clinicians safely and confidently prescribe oral antibiotics to young infants.
“The goal of the study is to determine the best oral antibiotic doses for young infants so they can leave the hospital sooner while still receiving effective treatment for their infection,” Haynes said.
A Safer Treatment for Pediatric Infections
Haynes is studying how infants 0-60 days old absorb and process two of the most commonly used antibiotics in pediatrics – amoxicillin and cephalexin. At this age, the most rapid developmental changes occur in babies’ intestines and kidneys. And this is when clinicians are the most hesitant to prescribe oral antibiotics.
“An infant in their first weeks of life might absorb an antibiotic over several hours, whereas a 6-month-old might absorb almost all of it within 30 to 60 minutes. Their kidneys get rid of the drug much slower, too. That’s why getting the dosing right is so critical,” Haynes explained.
Based on his findings, he will develop a model that links key infant characteristics – such as age and prematurity – to how quickly their intestines absorb and their kidneys eliminate antibiotics. This model will allow clinicians to tailor doses more accurately for each patient.
Once clinicians have a better understanding of how oral antibiotics are processed by young infants, they may be able to safely prescribe them for a range of serious infections, including urinary tract infections, bloodstream infections such as group B streptococcus (or GBS, a common cause of sepsis in newborns), pneumonia, and skin infections.
Overcoming Challenges with a Strong Research Infrastructure
Research with infants is challenging because many parents are hesitant to enroll their newborns in research studies that involve blood draws. Haynes and his research team typically approach between 10 and 20 families for every one that agrees to participate. Despite these challenges, Haynes said that it is important to him to study newborns and young infants because this group has historically been underrepresented in medical research.
Fortunately, CU Anschutz has resources like the CCTSI that make this possible. During the study, nurses from the CCTSI's pediatric Clinical Translational Research Center (CTRC) at Children’s Hospital Colorado administer oral antibiotics to infants in liquid form and collect blood samples.
“The research infrastructure at CU Anschutz allows me to accomplish something that would otherwise be extremely difficult. There are a lot of great resources here, like the CCTSI, that make it possible from a research perspective to accomplish something like this,” Haynes said.
Reducing the Burden on Volunteers
In his future research, Haynes plans to make studies less burdensome on volunteers, including finding the least-painful method to collect blood. Using mathematical modeling, he will determine the smallest amount of blood, and the fewest samples needed to meet study goals. He also plans to use Tasso Devices, which are small, button-like devices that make a small incision in the skin, to draw blood with minimal discomfort.
Ultimately, he hopes his study findings will give clinicians the confidence to prescribe oral antibiotics to young infants and help to reduce unnecessary hospital stays.
“When I tell other clinicians about my work, they tell me, ‘Wow, I’m so glad someone’s finally looking at that,’” Haynes said. “I think we as clinicians tend to overvalue the benefits of IV antibiotics and underestimate their risks. As a society, there’s a general distrust of oral antibiotics in really young babies, and hopefully we can change that.”
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