Table G.4

Bibliographic informationReason for exclusion
Andrews, R.E., Day, P., Bolsover, W.J., Audit of single daily dose gentamicin versus a variable frequency lower dose regimen in term and preterm neonates, British Journal of Intensive Care, 10, 42–46, 2000Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Ariano, R.E., Sitar, D.S., Davi, M., Zelenitsky, S.A., Bayesian pharmacokinetic analysis of a gentamicin nomogram in neonates: a retrospective study, Current Therapeutic Research, 64, 178–188, 2003Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Bajaj, M., Palmer, K., Gentamicin usage in newborns--a simple and practical regime, Pharmacy World and Science, 26, 242–244, 2004Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Begg, E.J., Vella-Brincat, J.W., Robertshawe, B., McMurtrie, M.J., Kirkpatrick, C.M., Darlow, B., Eight years’ experience of an extended-interval dosing protocol for gentamicin in neonates, Journal of Antimicrobial Chemotherapy, 63, 1043–1049, 2009Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Charlton, C.K., Needelman, H., Thomas, R.W., Kortas, K., Gentamicin dosage recommendations for neonates based on half-life predictions from birthweight, American Journal of Perinatology, 3, 28–32, 1986Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Contopoulos-Ioannidis, D.G., Giotis, N.D., Baliatsa, D.V., Ioannidis, J.P., Extended-interval aminoglycoside administration for children: a meta-analysis, Pediatrics, 114, e111–e118, 2004Systematic review and meta-analysis considered for review questions on antibiotics in the baby; includes children of all ages, all aminoglycosides, and studies from developing countries; reference list checked for relevant publications
Darmstadt, G.L., Miller-Bell, M., Batra, M., Law, P., Law, K., Extended-interval dosing of gentamicin for treatment of neonatal sepsis in developed and developing countries. [84 refs], Journal of Health, Population and Nutrition, 26, 163–182, 2008Systematic review considered for review questions on antibiotics in the baby; includes studies from developing countries; reference list checked for relevant publications
Davies, M.W., Cartwright, D.W., Gentamicin dosage intervals in neonates: longer dosage interval--less toxicity, Journal of Paediatrics and Child Health, 34, 577–580, 1998Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Dicenzo, R., Forrest, A., Slish, J.C., Cole, C., Guillet, R., A gentamicin pharmacokinetic population model and once-daily dosing algorithm for neonates, Pharmacotherapy, 23, 585–591, 2003Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Faura, C.C., Garcia, M.R., Horga, J.F., Changes in gentamicin serum levels and pharmacokinetic parameters in the newborn in the course of treatment with aminoglycoside, Therapeutic Drug Monitoring, 13, 277–280, 1991Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Garcia, B., Barcia, E., Perez, F., Molina, I.T., Population pharmacokinetics of gentamicin in premature newborns, Journal of Antimicrobial Chemotherapy, 58, 372–379, 2006Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Gooding, N., Elias-Jones, A., Shenoy, M., Gentamicin dosing in neonatal patients, Pharmacy World and Science, 23, 179–180, 2001Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Hagen, I., Oymar, K., Pharmacological differences between once daily and twice daily gentamicin dosage in newborns with suspected sepsis, Pharmacy World and Science, 31, 18–23, 2009Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Hale, L.S., Durham, C.R., A simple, weight-based, extended-interval gentamicin dosage protocol for neonates, American Journal of Health-System Pharmacy, 62, 1613–1616, 2005Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Hansen, A., Forbes, P., Arnold, A., O’Rourke, E., Once-daily gentamicin dosing for the preterm and term newborn: Proposal for a simple regimen that achieves target levels, Journal of Perinatology, 23, 635–639, 2003Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Hindmarsh, K.W., Nation, R.L., Williams, G.L., John, E., French, J.N., Pharmacokinetics of gentamicin in very low birth weight preterm infants, European Journal of Clinical Pharmacology, 24, 649–653, 1983Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Hoff, D.S., Wilcox, R.A., Tollefson, L.M., Lipnik, P.G., Commers, A.R., Liu, M., Pharmacokinetic outcomes of a simplified, weight-based, extended-interval gentamicin dosing protocol in critically ill neonates, Pharmacotherapy, 29, 1297–1305, 2009Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Illuzzi, J.L., Bracken, M.B., Duration of intrapartum prophylaxis for neonatal group B streptococcal disease: a systematic review. [34 refs], Obstetrics and Gynecology, 108, 1254–1265, 2006Considered for review question on intrapartum antibiotics; narrative review of pharmacokinetic studies in conclusion section of article; reference list checked for relevant studies
Lanao, J.M., Calvo, M.V., Mesa, J.A., Martin-Suarez, A., Carbajosa, M.T., Miguelez, F., Dominguez-Gil, A., Pharmacokinetic basis for the use of extended interval dosage regimens of gentamicin in neonates, Journal of Antimicrobial Chemotherapy, 54, 193–198, 2004Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Langlass, T.M., Mickle, T.R., Standard gentamicin dosage regimen in neonates, American Journal of Health-System Pharmacy, 56, 440–443, 1999Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Logdsen, B., Gentamicin 3 mg/kg dosing and monitoring within the first 7 days of life, J Pediatr Pharm Pract, 77–79, 1999Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Lopez-Samblas, A.M., Torres, C.L., Wang, H., Feuer, W.J., Goldberg, R.N., Effectiveness of a gentamicin dosing protocol based on postconceptional age: comparison to published neonatal guidelines, Annals of Pharmacotherapy, 26, 534–538, 1992Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Lundergan, F.S., Glasscock, G.F., Kim, E.H., Cohen, R.S., Once-daily gentamicin dosing in newborn infants, Pediatrics, 103, 1228–1234, 1999Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
McCracken, G.H., Jr., Chrane, D.F., Thomas, M.L., Pharmacologic evaluation of gentamicin in newborn infants, Journal of Infectious Diseases, 124 Suppl, S214–S223, 1971Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
McCracken, G.H., Jr., Ginsberg, C., Chrane, D.F., Thomas, M.L., Horton, L.J., Clinical pharmacology of penicillin in newborn infants, Journal of Pediatrics, 82, 692–698, 1973Considered for review question on antibiotics for suspected infection but excluded because the study investigated intramuscular penicillin which the GDG advised is not used in the UK
Murphy, J.E., Austin, M.L., Frye, R.F., Evaluation of gentamicin pharmacokinetics and dosing protocols in 195 neonates, American Journal of Health-System Pharmacy, 55, 2280-System, 1998Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Murphy, J.E., Prediction of gentamicin peak and trough concentrations from six extended-interval dosing protocols for neonates, American Journal of Health-System Pharmacy, 62, 823–827, 2005Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Murphy, J.E., Roether, A.M., Two nomograms for determining extended-dosing intervals for gentamicin in neonates.[Erratum appears in Am J Health Syst Pharm. 2008 May 1;65(9):795], American Journal of Health-System Pharmacy, 65, 624–630, 2008Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Nestaas, E., Bangstad, H.J., Sandvik, L., Wathne, K.O., Aminoglycoside extended interval dosing in neonates is safe and effective: a meta-analysis. [36 refs], Archives of Disease in Childhood Fetal and Neonatal Edition, 90, F294–F300, 2005Systematic review and meta-analysis considered for review questions on antibiotics in the baby; includes studies from developing countries and all aminoglycosides; reference list checked for relevant publications
Nielsen, E.I., Sandstrom, M., Honore, P.H., Ewald, U., Friberg, L.E., Developmental pharmacokinetics of gentamicin in preterm and term neonates: population modelling of a prospective study, Clinical Pharmacokinetics, 48, 253–263, 2009Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Ohler, K.H., Menke, J.A., Fuller, L., Use of higher dose extended interval aminoglycosides in a neonatal intensive care unit, American Journal of Perinatology, 17, 285–290, 2000Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Pacifici, G.M., Clinical pharmacokinetics of aminoglycosides in the neonate: a review. [65 refs], European Journal of Clinical Pharmacology, 65, 419–427, 2009Systematic review considered for review questions on antibiotics in the baby; reference list checked for relevant publications
Pacifici, G.M., Clinical pharmacokinetics of gentamicin in the neonate: A review, Current Topics in Pharmacology, 12, 119–127, 2008Systematic review considered for review questions on antibiotics in the baby; reference list checked for relevant publications
Pacifici, G.M., Clinical pharmacokinetics of penicillins, cephalosporins and aminoglycosides in the neonate: A review, Pharmaceuticals, 3, 2568–2591, 2010Systematic review considered for review questions on antibiotics in the baby; reference list checked for relevant publications
Pacifici, G.M., Labatia, J., Mulla, H., Choonara, I., Clinical pharmacokinetics of penicillins in the neonate: a review of the literature. [43 refs], European Journal of Clinical Pharmacology, 65, 191–198, 2009Systematic review considered for review questions on antibiotics in the baby; reference list checked for relevant publications
Pacifici, G.M., Peak and trough concentrations of gentamicin in the neonate: A review of the literature, Current Pediatric Reviews, 5, 2–7, 2009Systematic review of peak and trough gentamicin concentrations considered for review questions on antibiotics in the baby; includes studies conducted in developing countries; reference list checked for relevant publications
Rao, Shripada C., Srinivasjois, Ravisha, Hagan, Ronald, Ahmed, Mohmed, One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates, Cochrane Database of Systematic Reviews, -, 2010Cochrane review and meta-analysis considered for review questions on antibiotics in the baby; includes studies from developing countries; reference list checked for elevant publications
Rocha, M.J., Almeida, A.M., Falcao, A.C., Retrospective evaluation of gentamicin dosage guideline for premature neonates, The European Journal of Hospital Pharmacy Science, 12, 16–18, 2006Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Stickland, M.D., Kirkpatrick, C.M., Begg, E.J., Duffull, S.B., Oddie, S.J., Darlow, B.A., An extended interval dosing method for gentamicin in neonates, Journal of Antimicrobial Chemotherapy, 48, 887–893, 2001Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Sum, B.L., Veltkamp, S.A., Westerman, E.M., Sprij, A.J., Touw, D.J., An extended-interval gentamicin dosage regimen in newborns: a prospective study, EJHP Science, 13, 98–104, 2007Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Testa, M., Fanos, V., Martinelli, V., Stronati, M., Mussap, M., Del, Zompo M., Therapeutic drug monitoring of gentamicin in neonatal intensive care unit: experience in 68 newborns, Journal of Chemotherapy, 19 Suppl 2, 39–41, 2007Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Thingvoll, E.S., Guillet, R., Caserta, M., Dicenzo, R., Observational trial of a 48-hour gentamicin dosing regimen derived from Monte Carlo simulations in infants born at less than 28 weeks’ gestation, Journal of Pediatrics, 153, 530–534, 2008Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Thureen, P.J., Reiter, P.D., Gresores, A., Stolpman, N.M., Kawato, K., Hall, D.M., Once-versus twice-daily gentamicin dosing in neonates >/=34 Weeks’ gestation: cost-effectiveness analyses, Pediatrics, 103, 594–598, 1999Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Touw, D.J., Westerman, E.M., Sprij, A.J., Therapeutic drug monitoring of aminoglycosides in neonates. [77 refs][Erratum appears in Clin Pharmacokinet. 2009;48(3):209–10.], Clinical Pharmacokinetics, 48, 71–88, 2009Narrative review considered for review questions on antibiotics in the baby; reference list checked for relevant publications
Veltkamp, S.A., Westerman, E.M., Sprij, A.J., Sum, B.L., Touw, D.J., Gentamicin in preterm neonates: an extended interval dosing schedule, EJHP Science, 13, 92–97, 2007Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics
Vervelde, M.L., Rademaker, C.M.A., Krediet, T.G., Fleer, A., Van, Asten P, Van, Dijk A, Population pharmacokinetics of gentamicin in preterm neonates: Evaluation of a once-daily dosage regimen, Therapeutic Drug Monitoring, 21, 514–519, 1999Considered for review question on antibiotics for suspected infection but excluded because it is not a randomised controlled trial; more robust evidence from randomised controlled trials already included for gentamicin pharmacokinetics

From: Appendix G, Excluded studies

Cover of Antibiotics for Early-Onset Neonatal Infection
Antibiotics for Early-Onset Neonatal Infection: Antibiotics for the Prevention and Treatment of Early-Onset Neonatal Infection.
NICE Clinical Guidelines, No. 149.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2012 Aug.
Copyright © 2012, National Collaborating Centre for Women’s and Children’s Health.

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