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dc.creatorMahoney, L. (Liam)-
dc.creatorRaffaeli, G. (Genny)-
dc.creatorBeken, S. (Serdar)-
dc.creatorÜnal, S. (Sezin)-
dc.creatorKotidis, C. (Charalampos)-
dc.creatorCavallaro, G. (Giacomo)-
dc.creatorGarrido-Martínez-de-Salazar, F. (Felipe)-
dc.creatorBhatt, A. (Aomesh)-
dc.creatorDempsey, E.M. (Eugene M.)-
dc.creatorAllegaert, K. (Karel)-
dc.creatorSimons, S.H.P. (Sinno H. P.)-
dc.creatorFlint, R.B. (Robert B.)-
dc.creatorSmits, A. (Anne)-
dc.date.accessioned2024-01-09T10:54:21Z-
dc.date.available2024-01-09T10:54:21Z-
dc.date.issued2023-09-26-
dc.identifier.citationMAHONEY, Liam, et al. Grading the level of evidence of neonatal pharmacotherapy: midazolam and phenobarbital as examples. Pediatric Research, 2023, p. 1-9.es_ES
dc.identifier.issn10.1038/s41390-023-02779-9-
dc.identifier.urihttps://hdl.handle.net/10171/68222-
dc.description.abstractBACKGROUND: Many drugs are used off-label or unlicensed in neonates. This does not mean they are used without evidence or knowledge. We aimed to apply and evaluate the Grading and Assessment of Pharmacokinetic–Pharmacodynamic Studies (GAPPS) scoring system for the level of evidence of two commonly used anti-epileptic drugs. METHODS: Midazolam and phenobarbital as anti-epileptics were evaluated with a systematic literature search on neonatal pharmacokinetic (PK) and/or pharmacodynamic [PD, (amplitude-integrated) electroencephalography effect] studies. With the GAPPS system, two evaluators graded the current level of evidence. Inter-rater agreement was assessed for dosing evidence score (DES), quality of evidence (QoE), and strength of recommendation (REC). RESULTS: Seventy-two studies were included. DES scores 4 and 9 were most frequently used for PK, and scores 0 and 1 for PD. Inter-rater agreements on DES, QoE, and REC ranged from moderate to very good. A final REC was provided for all PK studies, but only for 25% (midazolam) and 33% (phenobarbital) of PD studies. CONCLUSIONS: There is a reasonable level of evidence concerning midazolam and phenobarbital PK in neonates, although using a predefined target without integrated PK/PD evaluation. Further research is needed on midazolam use in term neonates with therapeutic hypothermia, and phenobarbital treatment in preterms.es_ES
dc.language.isoenges_ES
dc.publisherSpringer Naturees_ES
dc.rightsinfo:eu-repo/semantics/closedAccesses_ES
dc.subjectMaterias Investigacion::Ciencias de la Salud::Pediatríaes_ES
dc.subjectNeonatal pharmacotherapyes_ES
dc.titleGrading the level of evidence of neonatal pharmacotherapy: midazolam and phenobarbital as exampleses_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.relation.publisherversionhttps://europepmc.org/article/med/37752246es_ES
dc.identifier.doi10.1038/s41390-023-02779-9-
dadun.citation.endingPage9es_ES
dadun.citation.publicationNamePediatric Researches_ES
dadun.citation.startingPage1es_ES
dc.identifier.pmid37752246-

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