1 Marchant EA, Boyce GK, Sadarangani M, et al. Neonatal sepsis due to coagulase-negative staphylococci. Clin Dev Immunol 2013; 2013: 586076.
2 Manzoni P, Rizzollo S, Decembrino L, et al. Recent advances in prevention of sepsis in the premature neonates in NICU. Early Hum Dev 2011; 87:S31–3.
3 Kadambari S, Heath PT, Sharland M, et al. Variation in gentamicin and vancomycin dosage and monitoring in UK neonatal units. J Antimicrob Chemother 2011; 66:2647–50.
4 Engle WA. Age terminology during the perinatal period. Pediatrics 2004; 114: 1362–4.
5 Clark RH, Bloom BT, Spitzer AR, et al. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics 2006; 117:1979–87.
6 Zingg W, Pfister R, Posfay-Barbe KM, et al. Secular trends in antibiotic use among neonates: 2001–2008. Pediatr Infect Dis J 2011; 30:365–70.
7 Zingg W, Posfay-Barbe KM. Antibiotic use in children—off-label use. Curr Drug Targets 2012; 13:885–92.
8 Neubert A, Lukas K, Leis T, et al. Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis. Eur J Clin Pharmacol 2010; 66:87–95.
9 Edmond K, Zaidi A. New approaches to preventing, diagnosing, and treating neonatal sepsis. PLoS Med 2010; 7: e1000213.
10 Lutsar I, Metsvaht T. Understanding pharmacokinetics pharmacodynamics in managing neonatal sepsis. Curr Opin Infect Dis 2010; 23: 201–7.
11 http://www.eucast.org
12 http://www.clsi.org
13 Asín E, Isla A, Canut A, et al. Comparison of antimicrobial pharmacokinetic/ pharmacodynamic breakpoints with EUCAST and CLSI clinical breakpoints for Gram-positive bacteria. Int J Antimicrob Agents 2012; 40:313–22.
14 Smits A, Annaert P, Allegaert K. Drug disposition and clinical practice in neonates: cross talk between developmental physiology and pharmacology. Int J Pharm 2013; 16:8–13.
15 Guidance for industry: exposure–response relationships—study design, data analysis, and regulatory applications. http://www.fda.gov/downloads/Drugs
16 European Medicines Agency. Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products. Ref.CPMP/EWP/2655/99). http://www.ema.europa.eu
17 European Medicines Agency. Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 1). http://www.ema.europa.eu
18 Setiabudy R, Suwento R, Rundjan L, et al. Lack of a relationship between the serum concentration of aminoglycosides and ototoxicity in neonates. Int J Clin Pharmacol Ther 2013; 51:401–6.
19 De Cock RFW, Allegaert K, Schreuder MF, et al. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet 2012; 51:105–17.
20 Abdel-Hady E, El Hamamsy M, Hedaya M, et al. The efficacy and toxicity of two dosing-regimens of amikacin in neonates with sepsis. J Clin Pharm Ther 2011; 36:45–52.
21 Schreuder MF, Wilhelm AJ, Bökenkamp A, et al. Impact of gestational age and birth weight on amikacin clearance on day 1 of life. Clin J Am Soc Nephrol 2009; 4:1774–8.
22 Siddiqi A, Khan DA, Khan FA, et al. Therapeutic drug monitoring of amikacin in preterm and term infants. Singapore Med J 2009; 50:486–9.
23 Sherwin CMT, Svahn S, Van der Linden A, et al. Individualised dosing of amikacin in neonates: a pharmacokinetic/pharmacodynamic analysis. Eur J Clin Pharmacol 2009; 65:705–13.
24 Allegaert K, Anderson BJ, van den Anker JN, et al. Renal drug clearance in preterm neonates: relation to prenatal growth. Ther Drug Monit 2007; 29:284–91.
25 Allegaert K, Cossey V, Debeer A, et al. The impact of ibuprofen on renal clearance in preterm infants is independent of the gestational age. Pediatr Nephrol 2005; 20:740–3.
26 Tréluyer JM, Merlé Y, Tonnelier S, et al. Nonparametric population pharmacokinetic analysis of amikacin in neonates, infants, and children. Antimicrob Agents Chemother 2002; 46:1381–7.
27 Labaune JM, Bleyzac N, Maire P, et al. Once-a-day individualized amikacin dosing for suspected infection at birth based on population pharmacokinetic models. Biol Neonate 2001; 80:142–7.
28 Wang J, Liang WQ, Wu JJ, et al. Population pharmacokinetic analysis of amikacin and validation on neonates using Monte Carlo method. Acta Pharmacol Sin 2000; 21:954–60.
29 Langhendries JP, Battisti O, Bertrand JM, et al. Adaptation in neonatology of the once-daily concept of aminoglycoside administration: evaluation of a dosing chart for amikacin in an intensive care unit. Biol Neonate 1998; 74:351–62.
30 Botha JH, du Preez MJ, Miller R, et al. Determination of population pharmacokinetic parameters for amikacin in neonates using mixed-effect models. Eur J Clin Pharmacol 1998; 53:337–41.
31 Petersen PO, Wells TG, Kearns GL. Amikacin dosing in neonates: evaluation of a dosing chart based on population pharmacokinetic data. Dev Pharmacol Ther 1991; 16:203–11.
32 Kenyon CF, Knoppert DC, Lee SK, et al. Amikacin pharmacokinetics and suggested dosage modifications for the preterm infant. Antimicrob Agents Chemother 1990; 34:265–8.
33 Admiraal R, van Kesteren C, Boelens JJ, et al. Towards evidence-based dosing regimens in children on the basis of population pharmacokinetic pharmacodynamic modelling. Arch Dis Child 2014; 99:267–72.
34 Jacqz-Aigrain E, Zhao W, Sharland M, et al. Use of antibacterial agents in the neonate: 50 years of experience with vancomycin administration. Semin Fetal Neonatal Med 2013; 18:28–34.
35 Cohen-Wolkowiez M, Ouellet D, Smith PB, et al. Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infants. Antimicrob Agents Chemother 2012; 56:1828–37.
36 Suyagh M, Collier PS, Millership JS, et al. Metronidazole population pharmacokinetics in preterm neonates using dried blood-spot sampling. Pediatrics 2011; 127:e367–374.
37 Pandolfini C1, Kaguelidou F, Sequi M, et al. Wide intra- and inter-country variability in drug use and dosage in very-low-birth-weight newborns with severe infections. Eur J Clin Pharmacol 2013;69:1031–6.
38 NICE Clinical Guidence: Antibiotics for early-onset neonatal infection. 2012.
39 Porta A, Hsia Y, Doerholt K, et al. Comparing neonatal and paediatric antibiotic prescribing between hospitals: a new algorithm to help international benchmarking. J Antimicrob Chemother 2012; 67:1278–86.
40 Neofax. Thomson Reuters Clinical Editorial Staff. 2011.
41 RedBook. American Academy of Pediatrics. 2013.
42 Kaguelidou F, Turner MA, Choonara I, et al. Randomized controlled trials of antibiotics for neonatal infections: a systematic review. Br J Clin Pharmacol 2013; 76:21–9.
43 Pansieri C, Bonati M, Choonara I, et al. Neonatal drug trials: impact of EU and US paediatric regulations. Arch Dis Child Fetal Neonatal Ed 2014; 99:F438.
44 Benjamin DK Jr, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 2006; 296:1266–73.
45 Nicklin S, Spencer SA. Recruitment failure in early neonatal research. Arch Dis Child Fetal Neonatal Ed 2004; 89:F281.
46 Amiel P, Moreau D, Vincent-Genod C, et al. Noninvitation of eligible individuals to participate in pediatric studies: a qualitative study. Arch Pediatr Adolesc Med 2007; 161:446–50.
Comentarios
Para ver los comentarios de sus colegas o para expresar su opinión debe ingresar con su cuenta de IntraMed.