{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T09:27:02Z","timestamp":1791192422591,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2013,6,20]],"date-time":"2013-06-20T00:00:00Z","timestamp":1371686400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2013,7]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>Antibiotics are a key resource for the management of infectious diseases in neonatology and their evaluation is particularly challenging. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials on antibiotics in neonatal infections.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a systematic search of <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>ub<jats:styled-content style=\"fixed-case\">M<\/jats:styled-content>ed, <jats:styled-content style=\"fixed-case\">E<\/jats:styled-content>mbase and the <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>ochrane <jats:styled-content style=\"fixed-case\">L<\/jats:styled-content>ibrary from <jats:styled-content style=\"fixed-case\">J<\/jats:styled-content>anuary 1995 to <jats:styled-content style=\"fixed-case\">M<\/jats:styled-content>arch 2010. Bibliographies of relevant articles were also hand\u2010searched. We included all randomized controlled trials that involved neonates and evaluated the use of an antibiotic agent in the context of a neonatal infectious disease. Methodological quality was evaluated using the Jadad scale and the <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>ochrane <jats:styled-content style=\"fixed-case\">R<\/jats:styled-content>isk of <jats:styled-content style=\"fixed-case\">B<\/jats:styled-content>ias <jats:styled-content style=\"fixed-case\">T<\/jats:styled-content>ool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 35 randomized controlled trials were evaluated. The majority were conducted in a single hospital institution, without funding. Median sample size was 63 (34\u2013103) participants. The most frequently evaluated antibiotic was gentamicin. Respectively, 18 (51%) and 17 (49%) trials evaluated the therapeutic or prophylactic use of antibiotics in various neonatal infections. Overall, the methodological quality was poor and did not improve over the years. Risk of bias was high in 66% of the trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Design and reporting of randomized controlled trials of antibacterial agents in neonates should be improved. Nevertheless, the necessity of implementing such trials when antibacterial efficacy has already been established in other age groups may be questioned and different methods of evaluation should be further developed.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.12113","type":"journal-article","created":{"date-parts":[[2013,3,14]],"date-time":"2013-03-14T01:01:13Z","timestamp":1363222873000},"page":"21-29","source":"Crossref","is-referenced-by-count":15,"title":["Randomized controlled trials of antibiotics for neonatal infections: a systematic review"],"prefix":"10.1111","volume":"76","author":[{"given":"Florentia","family":"Kaguelidou","sequence":"first","affiliation":[{"name":"Department of Paediatric Pharmacology and Pharmacogenetics INSERM CIC9202 APHP Hopital Robert Debr\u00e9  75019 Paris"},{"name":"Sorbonne Paris Cit\u00e9 Univ Paris Diderot  75019 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A.","family":"Turner","sequence":"additional","affiliation":[{"name":"Department of Women's and Children's Health University of Liverpool Neonatal Unit Liverpool Women's Hospital  Liverpool L8\u20097SS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imti","family":"Choonara","sequence":"additional","affiliation":[{"name":"Academic Division of Child Health University of Nottingham Derbyshire Children's Hospital  Derby UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"van Anker","sequence":"additional","affiliation":[{"name":"Division of Paediatric Clinical Pharmacology Children's National Medical Center  Washington, DC"},{"name":"Departments of Paediatrics, Pharmacology and Physiology George Washington University School of Medicine and Health Sciences  Washington, DC USA"},{"name":"Intensive Care Erasmus Medical Center\u2010Sophia Children's Hospital  Rotterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Manzoni","sequence":"additional","affiliation":[{"name":"Neonatology and NICU S. Anna Hospital  Torino Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corinne","family":"Alberti","sequence":"additional","affiliation":[{"name":"Sorbonne Paris Cit\u00e9 Univ Paris Diderot  75019 Paris France"},{"name":"Department of Clinical Epidemiology INSERM CIE5 APHP Hopital Robert Debre  75019 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Paul","family":"Langhendries","sequence":"additional","affiliation":[{"name":"NICU CHC\u2010Site St Vincent  4000 Rocourt\u2010Li\u00e8ge Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evelyne","family":"Jacqz\u2010Aigrain","sequence":"additional","affiliation":[{"name":"Department of Paediatric Pharmacology and Pharmacogenetics INSERM CIC9202 APHP Hopital Robert Debr\u00e9  75019 Paris"},{"name":"Sorbonne Paris Cit\u00e9 Univ Paris Diderot  75019 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,6,20]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.320.7227.79"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/fn.80.2.F142"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhpr021646"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10654-010-9480-2"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2006.03.015"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2009.173591"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/14767050903192192"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1179\/joc.2007.19.1.5"},{"key":"e_1_2_10_10_1","unstructured":"European Medicines Agency.Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products.2000. 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