Extended-interval gentamicin administration in neonates: a simplified approach

• Published in: Journal of perinatology 2016-08, Vol.36 (8), p.660-665
• Main Authors: El-Chaar, G M, Supaswud-Franks, T, Venugopalan, L, Kohn, N, Castro-Alcaraz, S
• Format: Article
• Language: English
• Subjects: 692/700/1720; 692/700/565/1436/2774; Administration, Intravenous; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - economics; Anti-Bacterial Agents - pharmacokinetics; Complications and side effects; Creatinine - blood; Dosage; Drug Administration Schedule; Drug dosages; Female; Follow-Up Studies; Gentamicin; Gentamicins - administration & dosage; Gentamicins - economics; Gentamicins - pharmacokinetics; Gestational Age; Health aspects; Health sciences; Humans; Infant, Newborn; Infant, Premature; Infants (Newborn); Infection - drug therapy; Intravenous administration; Male; Medicine; Medicine & Public Health; Microorganisms; Neonates; New York; Newborn babies; original-article; Patient outcomes; Patients; Pediatric Surgery; Pediatrics; Pharmacodynamics; Pharmacy; Prospective Studies; Side effects; Simulation; Statistical analysis
• ISSN: 0743-8346; 1476-5543
• DOI: 10.1038/jp.2016.37

Objective: Gentamicin dosing is highly variable and remains complicated in the neonatal population. Traditional dosing in our unit resulted in an excessive number of elevated trough serum gentamicin levels. We hypothesized that one uniform gentamicin dose for neonates of all gestational ages will reduce the incidence of elevated trough levels from 50 to 10%. Study Design: Our prospective, randomized, controlled trial enrolled eligible neonates into two groups, according to gestational age (⩽34 6/7 (group I) and >35 0/7 weeks (group II)). Patients in the study arm received a dose of gentamicin 5 mg kg −1 intravenous (i.v.) every 36 h, whereas patients in the control arm received traditional dosage. Patients were monitored for resolution of infection, serum gentamicin levels and adverse effects. We confirmed our findings in a follow-up study. Fisher’s exact and Mann–Whitney tests were used for statistical analysis. Results: We enrolled 96 neonates, 50 in group I ( n =25 per arm) and 46 in group II ( n =23 per arm). Elevated trough levels were reduced by 66% in group I ( P =0.61) and 100% in group II ( P =0.0015). In the study arm of both groups, 48/49 neonates had C min serum gentamicin concentration (SGC)