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Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates.

Publication ,  Journal Article
Hornik, CP; Benjamin, DK; Smith, PB; Pencina, MJ; Tremoulet, AH; Capparelli, EV; Ericson, JE; Clark, RH; Cohen-Wolkowiez, M ...
Published in: J Pediatr
November 2016

OBJECTIVE: To evaluate the relationship between ampicillin dosing, exposure, and seizures. STUDY DESIGN: This was a retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure predictions. We used the EHR from 348 Pediatrix Medical Group neonatal intensive care units from 1997 to 2012. We included all infants 24-41 weeks gestational age, 500-5400 g birth weight, first exposed to ampicillin prior to 25 days postnatal age. Using a 1-compartment pharmacokinetic model and EHR data, we simulated maximum ampicillin concentration at steady state (Cmaxss, µg/mL) and area under the concentration time curve from 0 to 24 hours (AUC24, µg*h/dL). Using multivariable logistic regression, we evaluated association between ampicillin dosing, exposure, and seizures as documented in the EHR. RESULTS: We identified 131 723 infants receiving 134 041 courses of ampicillin for 653 506 infant-days of exposure. The median daily dose was 200 mg/kg/d (25th, 75th percentile; 100, 200). Median Cmaxss and AUC24 were 256.6 µg/mL (164.3, 291.5) and 2593 µg*h/dL (1917, 3334). On multivariable analysis, dosing was not associated with seizures. However increasing Cmaxss (OR = 1.10, 95% CI 1.03, 1.17) and AUC24 (OR 1.11, 95% CI 1.05, 1.18) were associated with increased odds of seizures. CONCLUSIONS: In this cohort of hospitalized infants, higher ampicillin exposure was associated with seizures as documented in the EHR.

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Published In

J Pediatr

DOI

EISSN

1097-6833

Publication Date

November 2016

Volume

178

Start / End Page

125 / 129.e1

Location

United States

Related Subject Headings

  • Seizures
  • Risk Assessment
  • Retrospective Studies
  • Pediatrics
  • Models, Biological
  • Male
  • Logistic Models
  • Intensive Care Units, Neonatal
  • Infant, Newborn
  • Infant
 

Citation

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Chicago
ICMJE
MLA
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Hornik, C. P., Benjamin, D. K., Smith, P. B., Pencina, M. J., Tremoulet, A. H., Capparelli, E. V., … Best Pharmaceuticals for Children Act—Pediatric Trials Network, . (2016). Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates. J Pediatr, 178, 125-129.e1. https://doi.org/10.1016/j.jpeds.2016.07.011
Hornik, Christoph P., Daniel K. Benjamin, P Brian Smith, Michael J. Pencina, Adriana H. Tremoulet, Edmund V. Capparelli, Jessica E. Ericson, Reese H. Clark, Michael Cohen-Wolkowiez, and Michael Best Pharmaceuticals for Children Act—Pediatric Trials Network. “Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates.J Pediatr 178 (November 2016): 125-129.e1. https://doi.org/10.1016/j.jpeds.2016.07.011.
Hornik CP, Benjamin DK, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, et al. Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates. J Pediatr. 2016 Nov;178:125-129.e1.
Hornik, Christoph P., et al. “Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates.J Pediatr, vol. 178, Nov. 2016, pp. 125-129.e1. Pubmed, doi:10.1016/j.jpeds.2016.07.011.
Hornik CP, Benjamin DK, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M, Best Pharmaceuticals for Children Act—Pediatric Trials Network. Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates. J Pediatr. 2016 Nov;178:125-129.e1.
Journal cover image

Published In

J Pediatr

DOI

EISSN

1097-6833

Publication Date

November 2016

Volume

178

Start / End Page

125 / 129.e1

Location

United States

Related Subject Headings

  • Seizures
  • Risk Assessment
  • Retrospective Studies
  • Pediatrics
  • Models, Biological
  • Male
  • Logistic Models
  • Intensive Care Units, Neonatal
  • Infant, Newborn
  • Infant