Risk-Based EOS Approach Could Curb Antibiotics for Newborns

Diedtra Henderson

December 22, 2013

Antibiotic use could decrease for up to a quarter million newborns annually through the use of more-efficient evaluation and treatment of early-onset sepsis (EOS), using a new risk-stratification algorithm that factors in maternal risk and infants' clinical condition in the first hours of birth, according to a retrospective nested case-control study.

Gabriel J. Escobar, MD, from the Kaiser Permanente Division of Research and Perinatal Research Unit, Kaiser Permanente Division of Research, Oakland, California, and the Department of Inpatient Pediatrics, Kaiser Permanente Medical Center, Walnut Creek, California, and colleagues report their findings in an article published online December 23 in Pediatrics.

Although the incidence of EOS has dropped in the last 20 years, current guidelines take more of a shotgun approach, which resulted in 13% of 7004 infants being evaluated at a single Kaiser Permanente center for EOS and 11% being treated with antibiotics. However, only 0.04% of these infants had EOS confirmed by blood cultures, according to the authors.

The team devised a more targeted approach for EOS evaluation by assessing the birth mothers' risk factors (highest maternal antepartum temperature, gestational age, length of time a mother’s amniotic membranes were ruptured, group B Strep carriage status, and type of intrapartum antibiotic therapy received) and the evolving clinical conditions of the newborns in the first 12 hours after birth to enable clinicians to assign newborns to 1 of 3 groups. The smallest group would be treated with antibiotics, the second group could be treated on the basis of additional information, and the final group would be continually observed.

In 608,014 live births at 14 hospitals from 1993 to 2007, the researchers identified 350 EOS cases and matched them with 1063 control patients. The researchers applied the new risk-stratification scheme to determine that 4.1% of all live births (or 60.8% of the EOS cases) should have been treated with systemic antibiotics, pending negative culture results. Another 11.1% of all live births (or 23.4% of the EOS cases) merited more rigorous observation and formal evaluation with a blood culture. Antibiotics could have been prescribed on the basis of evolving clinical status or a positive culture, but 84.8% of live births (or 15.7% of the EOS cases) were determined to be low-risk and simply should have had continued observation.

The approach has the potential to result in decreased antibiotic use in 80,000 to 240,000 American newborns each year.

"Application of our risk stratification could have a major effect on hospital use. Currently, ~6% of newborns born at ≥34 weeks' gestation are treated with systemic antibiotics in the neonatal period in [Kaiser Permanente Northern California,] and ~10% in Brigham and Women's Hospital [in Boston, Massachusetts]. Using our strategy, this number would fall to 4%.It is likely that similar impacts would be seen in other settings," the authors note.

They caution that their results should be validated prospectively, especially at hospitals with different bacterial ecology and preferably by a randomized clinical trial that compares the new algorithm with the Centers for Disease Control and Prevention's recommended approach.

"Using sepsis risk at birth based on a maternal risk factors multivariate model and combining it with a newborn's evolving clinical examination, we have defined a risk stratification strategy for EOS," the authors conclude.

One study author reported receiving a grant from the National Institute of General Medical Sciences. The other authors have disclosed no relevant financial relationships.

Pediatrics. Published online December 23, 2013.

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