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| Link | rowid | title | DOI | URL | created | subject | references-count ▼ | is-referenced-by-count | ISSN | container-title | abstract | author_number | orcids | names | award_numbers | funder_names | funder_dois |
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| 52 | 52 | ["DEVELOPMENT AND ESTABLISHMENT OF A QUALITY-FRAMEWORK FOR THE LENA PROJECT"] | 10.1136/archdischild-2015-310148.72 | http://dx.doi.org/10.1136/archdischild-2015-310148.72 | 2015-12-15T08:07:33Z | ["Pediatrics, Perinatology, and Child Health"] | 0 | 0 | ["0003-9888", "1468-2044"] | Archives of Disease in Childhood | <jats:sec><jats:title>Background</jats:title><jats:p>The LENA (Labeling of Enalapril from Neonates up to Adolescents) project has been initiated to improve the healthcare of children with heart failure by an enalapril orodispersible mini-tablet. The LENA consortium combines academic clinical research centers, SMEs (small and medium-sized enterprises) and a patient/parent advocacy organization. The objective of the project requires to comply with respective GxP regulations like Good Manufacturing Practice (GMP), Good Clinical (Laboratory) Practice (GCP/“GCLP”1) and Good Vigilance Practice (GVP). The project team is comprised of sub-teams experienced in paediatric clinical practice, medicines development, clinical research and project management, but not all team members work in an appropriate quality framework. Aim: To establish a well-documented, efficient quality system applying a new approach for ensuring quality in all trial aspects by combining existing organization-related quality system elements of the project partners with newly developed SOPs and overarching, integrating trial-specific elements to ensure a reliable quality environment for the LENA Phase I clinical trial.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Based on the network-structure of the project organization, a strategy based on a team approach with joint responsibilities for the quality conduct of the project was pursuit, forming a QM Team consisting of the project leader, the leaders for pharmaceutical and clinical development and an external quality expert. The team compiled a quality manual and an organizational chart displaying the sub-teams and their responsibilities. Another responsibility of the team is the integration of existing SOPs and Work Instructions as well as the creation of procedures at the project level and furthermore the verification of appropriate qualification of all staff involved in the project through CVs, job descriptions and training records.</jats:p></jats:sec><jats:sec><jats:title>Resul… | 7 | [] | ["Agnes M. Ciplea", "Karl Kleine", "Bj\u00f6rn B. Burckhardt", "Stephanie L\u00e4er", "J\u00f6rg Breitkreutz", "Lucie \u0160patenkov\u00e1", "Ingrid Klingmann"] | [""] | [""] | [""] |
| 55 | 55 | ["MEDICATION USE IN NEONATAL INTENSIVE CARE UNITS ACROSS EUROPE"] | 10.1136/archdischild-2015-310148.11 | http://dx.doi.org/10.1136/archdischild-2015-310148.11 | 2015-12-15T08:07:33Z | ["Pediatrics, Perinatology, and Child Health"] | 0 | 0 | ["0003-9888", "1468-2044"] | Archives of Disease in Childhood | <jats:sec><jats:title>Objectives</jats:title><jats:p>This is the first Europe-wide study aiming to describe the medication use in Neonatal Intensive Care Units and to analyse the factors that might influence the prescription pattern.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A pan-European one day point-prevalence study was conducted in 2012 where all of the prescriptions for hospitalised neonates were recorded. A trade name, manufacturer, active pharmaceutical ingredients (API), strength, galenic form and route of administration were registered.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Altogether 2173 prescriptions were administered to 726 neonates from 21 countries, of whom 66% (477/726) were preterm, 12% (84/726) extremely preterm. There was inverse correlation between gestational age (GA) and median number of prescriptions per neonate (group median 2/IQR 1–4, extremely preterm 4/3–6, very preterm 3/2–5, late preterm 2/1–3, full-term 2/1–3). Median number of prescriptions per neonate was highest in the eastern region, among extremely preterm neonates (median=6.5/IQR 6–8.5). Highest prescription rate was for alimentary medicines (93/per 100 admissions), systemic antiinfectives (79/100) and medicines for blood (71/100). Antiinfectives were most frequently prescribed in the southern region (103/100). Multivitamins were most frequently used medications in most regions (western 74, southern 31, northern 31/100), except in eastern region (5/100). Most commonly prescribed API-s were multivitamins (32/100), caffeine (19/100), gentamicin (18/100), amino acids (18/100) and colecalciferol (15/100). Most frequently prescribed medications among extremely preterm neonates were caffeine (60/100), among very preterms multivitamins and caffeine (45 and 43/100), among late preterms multivitamins (44/100) and among full-terms phytomenadione (26/100) and gentamicin (24/100).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Our study revealed the most c… | 4 | [] | ["Inge Mesek", "Georgi Nellis", "Jana Lass", "Irja Lutsar"] | [""] | [""] | [""] |
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CREATE TABLE [article] ( [title] TEXT, [DOI] TEXT, [URL] TEXT, [created] TEXT, [subject] TEXT, [references-count] TEXT, [is-referenced-by-count] TEXT, [ISSN] TEXT, [container-title] TEXT, [abstract] TEXT, [author_number] TEXT, [orcids] TEXT, [names] TEXT, [award_numbers] TEXT, [funder_names] TEXT, [funder_dois] TEXT );