PEDIATRICS Vol. 103 No. 6 June 1999, pp. 1228-1234
Once-daily Gentamicin Dosing in Newborn Infants
Received Jun 9, 1998; accepted Dec 30, 1998.
§; Gregory
F. Glasscock*, 
,, and
From the * Stanford University School of Medicine, Stanford,
California, the 
Department of Pharmacy Practice, University of the
Pacific School of Pharmacy, Stockton, California; the Departments of
Pediatrics and § Pharmacy Services, Santa Clara Valley Medical
Center, San Jose, California.
Objective. We developed a simplified gentamicin dosing protocol for all neonates using a loading dose and once-daily dosing that would have an equal or lower incidence of toxicity and an equal or improved effectiveness compared with a regimen with no loading dose that included use of divided daily dosing.
Methods. All neonatal intensive care unit patients with a
postnatal age 
7 days and started on gentamicin therapy at the
discretion of the attending neonatologist were evaluated in this
comparative cohort study. All peak and trough serum drug levels (SDL),
pertinent demographic data, and markers of potential nephrotoxicity,
ototoxicity, and cure were tracked prospectively during 132 consecutive, nonrandomized courses of therapy on a new gentamicin
protocol. These were compared with data retrieved retrospectively
throughout 103 consecutive, nonrandomized courses of therapy in a
control group.
Results. Initial measured peak SDL were higher (7.8 ± 1.1 µg/mL vs 6.1 ± 1.0 µg/mL) and trough SDL were
lower (0.9 ± 0.2 µg/mL vs 2.7 ± 0.6 µg/mL) in the
protocol term subset, compared with the control term subset
(gestational age, 
37 weeks; weight, 2500 g). One hundred percent of
the initial and maintenance peak SDL in term protocol neonates were 5 to 12 µg/mL; compared with 84% of the initial and 61% of
maintenance peak SDL in the term control group. One hundred percent of
the initial and maintenance trough SDL were in the desired range of <2
µg/mL in term protocol neonates; compared with 70% of the initial
and 94% of maintenance trough SDL in the term control group. No
significant differences were found in any SDL in low birth
weight neonates (gestational age <37 weeks or weight <2500 g
and >1500 g) in the protocol compared with the control group. The very
low birth weight (weight <1500 g) protocol neonates had a
significantly higher mean initial trough SDL (2.3 ± 0.7 µg/mL
vs 1.5 ± 0.6 µg/mL) and a lower incidence of initial trough SDL
<2.0 µg/mL (30% vs 95%) than very low birth weight neonates in the
control group. No differences were seen between groups in incidence of
significant rise in serum creatinine or failure of hearing screen.
Conclusion. A loading dose followed by once-daily dosing was shown to result in SDL in the safe and therapeutic range in all term neonates in this study. In low birth weight neonates, this regimen resulted in peak and trough SDL throughout therapy that were similar to those observed in the control group. Delaying the initiation of maintenance once-daily dosing until 36 to 48 hours after the loading dose would be expected to result in a higher incidence of initial trough SDL in target range for very low birth weight neonates. Key words: neonates, gentamicin, loading dose, once-daily dosing.
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