Marika A de Hoop-Sommen, Tjitske M van der Zanden, Karel Allegaert, Robert B Flint, Sinno H P Simons, Saskia N de Wildt
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引用次数: 3
Abstract
Many drugs are used off-label in neonates which leads to large variation in prescribed drugs and dosages in neonatal intensive care units (NICUs). The NeoDose project aimed to develop best evidence dosing recommendations (DRs) for term and preterm neonates using a three-step approach: 1) drug selection, 2) establishing consensus-based DRs, and 3) establishing best evidence DRs.
Methods: The selection of drugs was based on frequency of prescribing, availability of a neonatal DR in the Dutch Pediatric Formulary, and the labeling status. Clinical need, pharmacological diversity, and Working Group Neonatal Pharmacology (WGNP) preferences were also taken into account, using a consensus-based approach. For the second step, we requested local dosing protocols from all ten Dutch NICUs and established consensus-based DRs within the WGNP, consisting of neonatologists, clinical pharmacologists, hospital pharmacists, and researchers. In the third step, the consensus-based DRs were compared with the available literature, using standardized PubMed searches.
Results: Fourteen drugs were selected for which the local dosing protocols were collected. These protocols differed mostly in total daily dose, dosing frequency, and/or route of administration. Strikingly, almost none of the dosing protocols of these 14 drugs distinguished between preterm and term neonates. The working group established consensus-based DRs, which after literature review needed modification in 56%, mainly in terms of a dose increase. Finally, we established 37 best evidence DRs, 22 for preterm and 15 for term neonates, representing 19 indications.
Conclusion: This project showed the successful three-step approach for the development of DRs for term and preterm neonates.
期刊介绍：
This highly respected and frequently cited journal is a prime source of information in the area of fetal and neonatal research. Original papers present research on all aspects of neonatology, fetal medicine and developmental biology. These papers encompass both basic science and clinical research including randomized trials, observational studies and epidemiology. Basic science research covers molecular biology, molecular genetics, physiology, biochemistry and pharmacology in fetal and neonatal life. In addition to the classic features the journal accepts papers for the sections Research Briefings and Sources of Neonatal Medicine (historical pieces). Papers reporting results of animal studies should be based upon hypotheses that relate to developmental processes or disorders in the human fetus or neonate.
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