NEW YORK (Reuters Health) – Researchers have developed a rapid genetic point-of-care test to help guide antibiotic therapy and avoid aminoglycoside-induced ototoxicity (AIO) in babies in the neonatal intensive-care unit (NICU).
The test detects the MT-RNR1 m.1555A>G variant, which predisposes to profound AIO.
“This is the first time ever that a point-of-care genetic test has been used in a medical setting when a rapid decision is required about which medicine to use,” Dr. William Newman of the Manchester Center for Genomic Medicine, Manchester University, United Kingdom, told Reuters Health by email.
“We have shown that it is possible to do this without adverse effects on the patient in terms of delays/wrong decisions,” Dr. Newman said.
Aminoglycosides remain the preferred first choice for empirical treatment of infection in the neonatal period. But for babies with the m.1555A>G variant, a cephalosporin-based regimen would be appropriate, the study says in JAMA Pediatrics.
Yet current genetic technologies are not sufficiently rapid to genotype m.1555A>G within a clinically relevant time frame in the acute setting. The rapid genetic test they developed for this variant can be completed in less than 30 minutes.
Dr. Newman and his colleagues tested it in a pragmatic, prospective, implementation study that included 751 neonates (median age, 2.5 days) from two large NICUs.
The test was successfully completed in 26 minutes, identified babies at risk of AIO, facilitated tailored prescribing, and did not disrupt normal clinical practice, the researchers report.
Three babies with the m.1555A>G variant were identified and all avoided aminoglycoside antibiotics. Overall, 424 infants (81%) receiving antibiotics were successfully tested for the variant, and the average time to antibiotic therapy was similar with and without use of the test.
The researchers say wide adoption of this test could significantly reduce the burden of AIO.
Dr. Newman said the test is currently being implemented at Manchester University Hospitals NHS Foundation Trust. “Nurses are undergoing training before going live in a couple of weeks,” he told Reuters Health.
“Our economic analyses estimate that it will save the publicly funded health service in the UK a minimum of £5 million per year through avoiding hearing loss in roughly 200 babies who otherwise would have required cochlear implants,” Dr. Newman added.
He also said there has been interest from centers in the U.S. keen to start using the test.
The author of an editorial says this novel point-of-care test will “undoubtedly” reduce the burden of AIO in newborns “but it is not likely to eliminate it.”
“The development of the point-of-care test has only moved the goal post,” Dr. De-Ann Pillers of the University of Illinois at Chicago writes.
“The goal should not be limited to screening for the risk of developing hearing loss, but must be broadened to the identification of novel therapeutics to reduce harm. Importantly, diagnostic testing to identify more specifically those with neonatal sepsis is an important mandate,” Dr. Pillers says.
“By having a targeted approach with reliable efficacy in sorting out who truly needs antibiotics, we will approach a safer world with fewer complications for newborns. Such complications are not limited to hearing loss but include adverse effects associated with the sepsis rule out itself with its incumbent unnecessary separation from the mother, delayed bonding, nephrotoxicity, and now the evolving concept of perturbation of the neonatal microbiome,” she adds.
The research did not have commercial funding. Dr. Newman has no relevant disclosures.
SOURCE: https://bit.ly/3D0wwdr and https://bit.ly/37PgCqX JAMA Pediatrics, online March 21, 2022.
Source: Read Full Article
