[Comparison of two gentamicin dosing schedules in the newborn].
BACKGROUND
Gentamicin is widely used in full-term neonates as empirical therapy for early-onset suspected or proven sepsis. Several dosing schedules for gentamicin have been recommended for this neonatal population.


OBJECTIVE
To compare gentamicin serum levels, efficacy and toxicity of two dosing schedules in term and preterm newborns.


METHODS
The study included 200 newborns who were started on gentamicin therapy. Group A (N=100) was prescribed a multiple-daily dosing regimen and Group B (N=100) on a once-daily dosing regimen. Newborns in Group A received gentamicin at 2.5-3.5 mg/kg/dose q12-18 h depending on postnatal age and serum creatinine levels, and newborns in Group B received 4-5 mg/kg/dose q24-48 h depending on postconceptional and postnatal age. All peak and trough serum drug levels, demographic data, and markers of potential nephrotoxicity and ototoxicity were compared.


RESULTS
Peak serum gentamicin levels were significantly higher (8.2+/-0.22 microg/ml vs. 5.9+/-0.13 microg/ml; p <or= 0.001) and trough levels were significantly lower (0.9+/-0.06 microg/ml vs. 1.7+/-0.08 microg/ml; p <or= 0.001) in Group B than in Group A. There was no significant difference between the groups either in the clinical failure rate or in the nephrotoxicity or ototoxicity outcomes.


CONCLUSIONS
Once-daily dosing regimen of gentamicin in preterm and term newborns is safe and effective, with a reduced risk of serum drug concentrations falling outside the therapeutic range.
Servicio de Pediatría, Sección de Neonatología, Hospital General Universitario de Alicante, Alicante, España. mgonzalezsantacruz@yahoo.es
M
M
González Santacruz
J L
JL
Tarazona Fargueta
P
P
Ferrandis Rodríguez
C
C
Tapia Collados
B
B
Jiménez Cobo
D003404:Creatinine / Q000378:metabolism; D004334:Drug Administration Schedule; D005839:Gentamicins / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D011446:Prospective Studies; D018746:Systemic Inflammatory Response Syndrome / Q000188:drug therapy*
D005839:Gentamicins; D003404:Creatinine