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Once-daily gentamicin dosing for the preterm and term newborn: proposal for a simple regimen that achieves target
Anne Hansen1, Peter Forbes, Alana Arnold
1Division of Newborn Medicine, Children's Hospital, Boston, MA, USA.
Insights
Once-daily gentamicin dosing is effective for preterm and term newborns, simplifying treatment and achieving therapeutic drug levels. This approach reduces dosing errors and improves safety in neonatal intensive care units.
Area of Science:
- Neonatal pharmacokinetics
- Antibiotic stewardship
- Pediatric pharmacology
Background:
- Current gentamicin dosing regimens in neonates can be complex and lead to errors.
- Limited data exist on once-daily gentamicin use in preterm infants.
- Optimizing gentamicin dosing is crucial for efficacy and minimizing toxicity in newborns.
Purpose of the Study:
- To develop and evaluate a simplified, once-daily gentamicin dosing guideline for preterm and term neonates.
- To assess the achievement of target trough and peak gentamicin serum levels with the new regimen.
- To improve the safety and efficiency of gentamicin administration in a Neonatal Intensive Care Unit.
Main Methods:
- A once-daily gentamicin dosing regimen was designed based on literature review and pharmacokinetic analysis: 3 mg/kg for <35 weeks gestation and 4 mg/kg for >=35 weeks gestation.
- Target serum levels were defined as trough <= 2 microg/ml and peak between 6-12 microg/ml.
- Trough and peak levels were analyzed for infants receiving the regimen for at least 72 hours in the first week of life.
Main Results:
- A total of 214 infants were included, with 75 <35 weeks gestation.
- 100% of infants achieved nontoxic trough levels (< or =2 microg/ml).
- Therapeutic peak levels (6-12 microg/ml) were achieved in 79% of infants <35 weeks and 93% of infants >=35 weeks gestation.
Conclusions:
- Once-daily gentamicin administration is a simple and effective dosing strategy for both preterm and term newborns.
- The proposed regimen achieves a high proportion of desirable gentamicin serum levels, including in preterm infants.
- This guideline is recommended for routine use in neonatal care to optimize gentamicin therapy.
Objective:
Based on recent safety and efficacy data, combined with the known pharmacokinetic parameters of aminoglycosides in the newborn, once-daily gentamicin should be preferable to the many other dosing regimens currently in use. Although there are growing data to support its use in term newborns, experience with preterm infants is more limited. In our Neonatal Intensive Care Unit, we experienced difficulties regarding complicated dosing regimens, actual dosing errors, and the tendency to check trough and peak levels around the third dose for infants receiving only a 48 hour course. Therefore, we conducted a quality improvement initiative in which we developed and tested a clinical practice guideline for the use of once-daily gentamicin for preterm and term infants that we hoped would yield trough and peak levels in our target range.
Methods:
We combined a review of the published English language literature with pharmacokinetic analysis of our own data prior to initiation of this new regimen to design the following dosing regimen: <35 weeks gestation: 3 mg/kg q 24 hours, > or =35 weeks gestation: 4 mg/kg q 24 hours. Our goal serum levels were a trough < or =2 microg/ml and a peak between 6 and 12 microg/ml. We collected and analyzed trough and peak levels from all infants receiving this dosing regimen in the first week of life for at least 72 hours between 3/1/99 and 12/31/00.
Results:
In total, 214 babies met our inclusion criteria, 75 of whom were <35 weeks gestation. 100% of babies of all gestational ages had a nontoxic trough level. For infants <35 weeks gestation, 79% had a therapeutic peak level, with a mean value of 6.8 microg/ml. For infants of at least 35 weeks gestation, 93% had a therapeutic peak level, with a mean value of 8.4 microg/ml. 92% of nontherapeutic peaks were too low.
Conclusion:
This study of once-daily gentamicin represents the largest sample size of pre-term infants published to date. The proposed regimen is simple and yields a high proportion of desirable levels. We recommend it for use in preterm and term newborns.
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