Objective: To determine the safety of gentamicin when used in a community setting to treat neonatal sepsis.
Methods: The study was conducted in peri-urban areas of Karachi from September 2009 to April 2010. The exposed group consisted of children 6 months to 3 years of age who were treated for sepsis during 0-2 months of age in the community, with a regimen that included gentamicin for at least five days.The control group included children from the same area who never received gentamicin. The outcome measure was hearing loss, which was assessed by Brainstem Evoked Response Audiometry.
Results: Of the 255 children enrolled, 125 (49%) received gentamicin, while 130 (51%) were not exposed to gentamicin. Children in the gentamicin exposed group were not at increased risk for hearing loss compared to controls (n = 30; 30.9% vs. n = 33; 31.4%, RR 0.98; 95% Cl: 0.60-1.61). Children with history of ear discharge (RR 1.7) and children with family history of deafness (RR 2.0) were more at risk for having hearing loss.
Conclusion: No association was found between hearing loss and gentamicin exposure in a community setting for the management of sepsis in the first two months of life.