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  • ["Pediatrics, Perinatology, and Child Health"] · 9
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
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"] [""] [""] [""]
98 ["Children with chronic health disorders travelling to the tropics: a prospective observational study"] 10.1136/archdischild-2015-309436 http://dx.doi.org/10.1136/archdischild-2015-309436 2016-06-11T04:55:23Z ["Pediatrics, Perinatology, and Child Health"] 19 0 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Background</jats:title><jats:p>The number of trips to the tropics taken by children with chronic health disorders (CHDs) is increasing.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>All of the children with CHDs who attended two international vaccination centres in France before travelling to the tropics were included in a prospective, exposed/unexposed study. Each child was age-matched with two control children and followed for 1 month after returning from the tropics.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Fifty-six children with CHDs and 107 control children were included. The children's median age was 6 years old (IQR 2–11). Of the study participants, 127/163 (78%) travelled to West Africa, mainly to visit relatives. The median duration of the stay was 42 days (IQR 31–55). The age of the children, the destination and the duration of the trip were similar between the two groups. Sickle cell disease (23/56) and asthma (16/56) were the most common CHDs. Overall, the children with CHDs experienced more clinical events than the control patients did (p&lt;0.05); however, there was no difference when chronic disease exacerbations were excluded (p=0.64) or when only the period abroad was considered (p=0.24). One child with a recent genetic diagnosis of atypical haemolytic uraemic syndrome died from a first disease exacerbation.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Health problems among children with CHDs travelling abroad are mainly related to chronic disease exacerbations, which mostly occur after the children return. Patients with diseases that require highly specialised care for an exacerbation should avoid travelling to resource-limited tropical countries.</jats:p></jats:sec> 12 [] ["Camille Ducrocq", "Julie Sommet", "Dora Levy", "Thanh-Van Trieu", "Fabrice Quercia", "Laurence Morin", "Xavier Belletre", "B\u00e9reng\u00e8re Koehl", "Frederic Sorge", "Corinne Alberti", "Loic de Pontual", "Albert Faye"] [""] [""] [""]
45 ["Success of 4CMenB in preventing meningococcal disease: evidence from real-world experience"] 10.1136/archdischild-2019-318047 http://dx.doi.org/10.1136/archdischild-2019-318047 2020-02-06T22:15:25Z ["Pediatrics, Perinatology, and Child Health"] 0 1 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:p>Meningococcal disease remains one of the most feared infectious diseases worldwide because of its sudden onset, rapid progression and high case fatality rates, while survivors are often left with severe long-term sequelae. Young children have the highest incidence of invasive meningococcal disease (IMD), and nearly all cases in the UK, as in most of Europe and many other industrialised countries, are due to group B meningococci (MenB). The licensure of a broad-coverage, recombinant protein-based MenB vaccine (4CMenB) in 2013 was, therefore, heralded a major breakthrough in the fight against IMD. This vaccine was, however, licensed on immunogenicity and reactogenicity studies only, raising uncertainties about field effectiveness, long-term safety and antibody persistence. In 2015, the UK became the first country to implement 4CMenB into the national infant immunisation schedule and, since then, several countries have followed suit. Seven years after licensure, a wealth of real-world data has emerged to confirm 4CMenB effectiveness, along with large-scale safety data, duration of protection in different age groups, successful strategies to reduce vaccine reactogenicity, impact on carriage in adolescents and the potential for 4CMenB to protect against other meningococcal serogroups and against gonorrhoea. A number of questions, however, remain unanswered, including the investigation and management of vaccine-associated fever in infants, as well as disease severity and assessment of breakthrough cases in immunised children. Increasing use of 4CMenB will provide answers in due course. We now have vaccines against all the major serogroups causing IMD worldwide. Next-generation and combination vaccines against multiple serogroups look very promising.</jats:p> 4 [] ["Catherine Isitt", "Catherine A Cosgrove", "Mary Elizabeth Ramsay", "Shamez N Ladhani"] [""] [""] [""]
43 ["Thyroid scintigraphy differentiates subtypes of congenital hypothyroidism"] 10.1136/archdischild-2019-317665 http://dx.doi.org/10.1136/archdischild-2019-317665 2019-11-14T22:15:30Z ["Pediatrics, Perinatology, and Child Health"] 0 1 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Introduction</jats:title><jats:p>UK screening for congenital hypothyroidism (CH) is based on dried blood spot Thyroid Stimulating Hormone (TSH). Scintigraphy may identify CH subtypes classified as dysplasia, gland in situ (GIS) and ectopia, but is not performed in all centres. We retrospectively investigated the role of scintigraphy to identify CH subtypes in a single tertiary centre cohort.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Babies who screened positive for CH between 2007 and 2017 were studied (n=418 of 534 783). Scintigraphy outcomes were correlated with TSH and levothyroxine dose. GIS patients were analysed for 3-year outcomes.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>303 patients started levothyroxine. Scintigraphy demonstrated three subtypes: GIS (n=139, 46%) ectopia (n=84, 28%) and dysplasia (n=80, 26%). Three-year follow up demonstrated permanence in 54% of 37 GIS cases.</jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p>Thyroid scintigraphy differentiates subtypes of CH and suggests a higher than expected proportion of patients with GIS and ectopia. CH is permanent in half of those with GIS.</jats:p></jats:sec> 6 [] ["Chris Worth", "Beverly Hird", "Lesley Tetlow", "Neville Wright", "Leena Patel", "Indraneel Banerjee"] [""] [""] [""]
40 ["Infant sleep and child mental health: a longitudinal investigation"] 10.1136/archdischild-2019-318014 http://dx.doi.org/10.1136/archdischild-2019-318014 2020-03-10T03:55:23Z ["Pediatrics, Perinatology, and Child Health"] 25 1 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Objective</jats:title><jats:p>To determine whether infants with severe persistent sleep problems are at increased risk of (1) meeting diagnostic criteria for a psychiatric disorder (age 10 years), and (2) having elevated symptoms of mental health difficulties (ages 4 and 10 years), in comparison with infants with settled sleep.</jats:p></jats:sec><jats:sec><jats:title>Design and setting</jats:title><jats:p>Prospective longitudinal community cohort study—the Maternal Health Study. Mothers completed questionnaires/interviews at 15 weeks' gestation; 3, 6, 9 and 12 months post partum; and when their child turned 4 and 10 years old. Measures included parental report of infant night waking and sleep problems and child mental health (Strengths and Difficulties Questionnaire; Spence Children’s Anxiety Scale; Development and Well-being Assessment).</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>1460 mother-infant dyads.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>283 (19.4%) infants had persistent severe sleep problems, 817 (56.0%) had moderate/fluctuating sleep problems and 360 (24.7%) infants were settled. Infants with persistent severe sleep problems were more likely to report emotional symptoms at age 4 (adjusted odds ratio (AOR)=2.70, 95% CI 1.21 to 6.05, p=0.02), and meet diagnostic criteria for an emotional disorder at age 10 (AOR=2.37, 95% CI 1.05 to 5.36, p=0.04). Infants with persistent severe sleep problems also had elevated symptoms of separation anxiety (AOR=2.44, 95% CI 1.35 to 4.41, p&lt;0.01), fear of physical injury (AOR=2.14, 95% CI 1.09 to 4.18, p=0.03) and overall elevated anxiety (AOR=2.20, 95% CI 1.13 to 4.29, p=0.02) at age 10.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Infants with persistent severe sleep problems during the first postnatal year have an increased risk of anxiety problems and emotional disorders at age 10.</jats:p></jats:sec> 6 ["http://orcid.org/0000-0001-6477-3940"] ["Fallon Cook", "Laura J Conway", "Rebecca Giallo", "Deirdre Gartland", "Emma Sciberras", "Stephanie Brown"] ["199222", "433006", "491205"] ["National Health and Medical Research Council", "Victorian Government Operational Infrastructure Support Program"] ["10.13039/501100000925", [""]]
9 ["Season and region of birth as risk factors for coeliac disease a key to the aetiology?"] 10.1136/archdischild-2015-310122 http://dx.doi.org/10.1136/archdischild-2015-310122 2016-08-16T01:13:27Z ["Pediatrics, Perinatology, and Child Health"] 39 11 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Background</jats:title><jats:p>Coeliac disease (CD) incidence has increased in recent decades, characterised by variations according to sex, age at diagnosis, year of birth, month of birth and region of birth. Genetic susceptibility and exposure to gluten are the necessary factors in CD aetiology, although several environmental factors are considered.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A nationwide prospective cohort longitudinal study was conducted consisting of 1 912 204 children aged 0–14.9 years born in Sweden from 1991 to 2009. A total of 6569 children were diagnosed with biopsy-verified CD from 47 paediatric departments. Using Cox regression, we examined the association between CD diagnosis and season of birth, region of birth and year of birth.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Overall, CD risk was higher for children born during spring, summer and autumn as compared with children born during winter: adjusted HR for spring 1.08 (95% CI 1.01 to 1.16), summer 1.10 (95% CI 1.03 to 1.18) and autumn 1.10 (95% CI 1.02 to 1.18). Increased CD risk was highest if born in the south, followed by central Sweden when compared with children born in northern Sweden. Children diagnosed at &lt;2 years had an increased CD risk if born in spring while those diagnosed at 2–14.9 years the risk was increased for summer and autumn births. The birth cohort of 1991–1996 had increased CD risk if born during spring, for the 1997–2002 birth cohort the risk increased for summer and autumn births, while for the birth cohort of 2003–2009 the risk was increased if born during autumn.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Season of birth and region of birth are independently and jointly associated with increased risk of developing CD during the first 15 years of life. Seasonal variation in infectious load is the likely explanation.</jats:p></jats:sec> 5 [] ["Fredinah Namatovu", "Marie Lindkvist", "Cecilia Olsson", "Anneli Ivarsson", "Olof Sandstr\u00f6m"] [""] [""] [""]
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"] [""] [""] [""]
74 ["SELF-ADMINISTRATION OF IN-PATIENT MEDICATIONS: A PILOT STUDY IN CHILDREN WITH CYSTIC FIBROSIS"] 10.1136/archdischild-2016-311535.70 http://dx.doi.org/10.1136/archdischild-2016-311535.70 2016-08-18T07:07:30Z ["Pediatrics, Perinatology, and Child Health"] 1 0 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Introduction</jats:title><jats:p>Children with Cystic Fibrosis (CF) have complex medication regimens, where responsibility for administration usually lies with the parent/carer until the child is older and able to take over this role.1 On admission to hospital this role is usually undertaken by nurses, leaving patients/parents/carers feeling disempowered, and unprepared for discharge.</jats:p></jats:sec><jats:sec><jats:title>Aims</jats:title><jats:p>All CF admissions to be offered the Self-Administration Of Medicines Scheme (SAM).</jats:p><jats:p>▸ Empower patients/parents/carers with responsibility of administering their own medications</jats:p><jats:p>▸ Reduce nursing time</jats:p><jats:p>▸ Educate patients/parents/carers about their medications</jats:p><jats:p>▸ Cost-saving by utilising Patients Own Medicines (PODs).</jats:p></jats:sec><jats:sec><jats:title>Method</jats:title><jats:p>A policy and training programme was developed and approved by the Trust's Medicines Management Board. This provided a framework for staff to use so that they may:</jats:p><jats:p>▸ Obtain consent</jats:p><jats:p>▸ Evaluate and re-use PODs</jats:p><jats:p>▸ Safely store and obtain supplies</jats:p><jats:p>▸ Continuously negotiate accountability for administration with patient/parent/carer.</jats:p><jats:p>The study was conducted over a 10 month period, where all families with CF admitted, were assessed for participation in SAM. The nursing teams acted as the primary assessors for SAM and any concerns were referred to the paediatric CF multidisciplinary team. To evaluate the pilot, families were given questionnaires to establish their views about the scheme. Nurses were asked to feedback if SAM decreased time for medication administration. To evaluate the associated cost-saving, data on PODs suitable for re-use was collected.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>159 children with CF were admitted to the ward, 95 (60%) were assessed to participate in the scheme and 64 (40%) of the… 7 [] ["Khola Khan", "Aoife Harrington", "Rupinder Pannu", "Sian Bentley", "Sukeshi Makhecha", "Nimla Pentayya", "Clare Pheasant"] [""] [""] [""]
68 ["Drug utilisation among Dutch adolescents: a pharmacy prescription records study"] 10.1136/archdischild-2017-314692 http://dx.doi.org/10.1136/archdischild-2017-314692 2018-06-01T16:16:30Z ["Pediatrics, Perinatology, and Child Health"] 12 0 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Background</jats:title><jats:p>Studies on adolescent drug use are scarce as most studies do not distinguish between children and adolescents. Therefore, we assessed overall drug use in adolescents.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A retrospective cohort study was conducted using pharmacy dispensing records from 62 community pharmacies in the Netherlands. Dispensing records of the previous 5 years were extracted for adolescents (12–18 years).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The study population consisted of 47 421 adolescents who collected at least one medication prescription during adolescence (mean age 15.5±1.8 years; 48.9% males). Half of them collected dermatologicals (46.2% males; 52.3% females), followed by drugs for the respiratory system (43.4% males; 40.3% females) and anti-infectives for systemic use (31.3% males; 39.1% females). The percentage of males using dermatologicals slightly increased, while the percentage of female users decreased with age. The most prescribed active ingredient was methylphenidate.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>These insights into adolescent drug use help us to better understand adolescent healthcare use.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>Dutch trial register NTR5061.</jats:p></jats:sec> 4 ["http://orcid.org/0000-0001-9059-1278"] ["Richelle C Kosse", "Ellen S Koster", "Tjalling W de Vries", "Marcel L Bouvy"] [""] [""] [""]

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