A National Institutes of Health multisite study could lead to a consistent standard of care for antibiotic administration in NICUs.
By Michelle Ryan
The Division of Neonatology at USA Health Children’s & Women’s Hospital was recently selected as a research site for a nationwide multicenter study funded by the National Institutes of Health (NIH).
The Neonatal Intensive Care Unit (NICU) Antibiotics and Outcomes Trial (NANO) will study routine antibiotic usage in extremely premature infants and gain insight into the long-term impacts.
Manimaran (Maran) Ramani, M.D., M.S.H.A., M.S.H.Q.S., division chief for Neonatal and Perinatal Medicine, will lead the NANO trial at USA Health.
“Our NICU is one of the largest of its kind and known to provide care for a very large number of extremely premature infants,” Ramani said. The NANO study team plans to enroll 802 infants and mothers across 16 sites in the United States.
The study began in 2020 and will conclude in 2024. It was designed to determine whether routine antibiotic usage in extremely premature infants (fewer than 29 weeks of gestation) is linked to gut microbiota changes and results in higher adverse outcomes, such as sepsis, necrotizing enterocolitis or death.
Gut microbiota refers to the trillions of microbes, such as bacteria, that exist within the human digestive system and help support energy harvesting, digestion and immune defense. While most microbes in the body are useful, they may become harmful when out of balance.
“Completion of this trial may position us to conclude that empiric antibiotic therapy (treatment for an anticipated or likely cause of infectious disease) worsens outcomes or that empiric antibiotics improve outcomes in premature infants,” Ramani said. “If the former is true, results could rapidly be translated into a decrease in antibiotic usage in NICUs.”
Administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life without clear evidence of infection has been a longstanding practice. Several recent studies in preterm infants have identified associations between early antibiotic exposure and necrotizing enterocolitis and late onset sepsis. As a result, antibiotic stewardship initiatives have been widely adopted in NICUs and have successfully reduced the length of early antibiotic therapy. But extremely low birthweight babies continue to receive at least a short course of antibiotics at birth.
“Should we find worsened outcomes with antibiotic administration, this trial would provide physicians with confidence not to use empiric antibiotics. It is also possible that significant differences will not be observed between study groups,” Ramani said.
The Hollis J. Wiseman Neonatal Intensive Care Unit at Children's & Women's Hospital is the area’s only Level III NICU. Infants in the NICU are cared for around the clock by an expert team of neonatologists, nurses, educators, therapists and other staff. The 98-bed NICU admits more than 1,000 infants each year.
USA Health also has the area’s only neonatal transport team to provide life support and advanced care to fragile and critically ill newborns during emergency ambulance transport to Children’s & Women’s Hospital.