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Le Touquet – Paris-Plage, France

Chappuy H.,University of Paris Descartes | Baruchel A.,University Paris Diderot | Leverger G.,University Paris - Sud | Oudot C.,University Paris Diderot | And 7 more authors.
Archives of Disease in Childhood | Year: 2010

Objective: To evaluate the extent to which parents are satisfied with and understand the information they are given when their consent is sought for their child to participate in a phase III randomised clinical trial and the reasons for their decision. Patients and method: The authors carried out a prospective study. The authors included all parents whose consent was sought for their child to participate in the FRALLE 2000A protocol (acute lymphoblastic leukaemia) at two centres. The parents were questioned twice by a qualified psychologist using a semidirected interview, 1 and 6 months after consent was sought. Results: 43 first interviews were carried out. All the parents declared they were satisfied with the explanations provided by the physician. 35 (81%) parents felt that the information provided with the request for consent was appropriate. Eight (19%) parents did not realise that their child had been included in a research protocol. 16 (39%) parents did not understand the concept of randomisation. Half the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one third of the parents were aware that they had an alternative. The principal factor underlying their decision, as stated by 29 parents (67%), was confidence in the medical team. Conclusions: The parents signed consent forms without having fully understood all the elements specific to the experimental protocol. Rather, the parents based their decision on their confidence in the medical team, even when their child's life was at risk. Source

Choleau C.,LAide Aux Jeunes Diabetiques AJD | Maitre J.,LAide Aux Jeunes Diabetiques AJD | Maitre J.,University of Paris Pantheon Sorbonne | Elie C.,University of Paris Pantheon Sorbonne | And 11 more authors.
Archives de Pediatrie | Year: 2015

The aim of the study was to evaluate, after the first year of a national information campaign, the effect on the frequency and severity of diabetic ketoacidosis (DKA) at diagnosis of type 1 diabetes (T1D) in children and adolescents in France. The following data were collected during a 2-year period in people younger than 15years of age at diagnosis of T1D, in 146pediatric centers: age, sex, duration of symptoms, patient's previous care, clinical and biological signs, and family history of T1D. DKA was defined as pH. <. 7.30 or bicarbonate. <. 15. mmol/L, severe DKA as pH. <. 7.10 or bicarbonate <. 5. mmol/L. During the 2nd year, an information campaign targeting health professionals and families was launched with the objective of reducing the time to diagnosis. Data were compared between the year before the campaign (year 0) and the first year of the campaign (year 1). The number of new cases of T1D was 1299 for year 0 and 1247 for year 1. Between year 0 and year 1, the rate of DKA decreased from 43.9% to 40.5% (. P=. 0.08), exclusively due to the decrease of severe DKA from 14.8 to 11.4% (. P=. 0.01). In the 0- to 5-year-old and 5- to 10-year-old age groups, the relative decrease in the rate of DKA was 13% and 15%, and 23% and 41% for severe DKA, respectively. In patients referred to the hospital by a pediatrician or who came at the family's initiative, the decrease was 34% and 7%, and 39% and 32% for severe DKA, respectively. No change was observed in the 10- to 15-year-old group or in those children who were referred by a general practitioner. In multivariate analyses, a higher DKA rate was associated with the young age of the child (<. 5 years), being hospitalized at the parents' initiative rather than being referred by a doctor, and the absence of a family history of T1D. A higher rate of severe DKA was associated with these last two factors but not with the child's age. The frequency of DKA at diagnosis of type 1 diabetes remains high in children and adolescents, but the first year of an information campaign decreased it. The results have also helped better define the strategy and targets of the continuing prevention campaign, to more efficiently reduce the morbidity and mortality of T1D at diagnosis in children and adolescents in France. © 2014 Elsevier Masson SAS. Source

Menoni V.,Unite Of Recherche Clinique Paris Center | Menoni V.,University of Paris Descartes | Lucas N.,University of Paris Descartes | Leforestier J.-F.,University of Paris Descartes | And 9 more authors.
PLoS ONE | Year: 2011

Background: The aim was to evaluate the readability of research information leaflets (RIL) for minors asked to participate in biomedical research studies and to assess the factors influencing this readability. Methods and Findings: All the pediatric protocols from three French pediatric clinical research units were included (N = 104). Three criteria were used to evaluate readability: length of the text, Flesch's readability score and presence of illustrations. We compared the readability of RIL to texts specifically written for children (school textbooks, school exams or extracts from literary works). We assessed the effect of protocol characteristics on readability. The RIL had a median length of 608 words [350 words, 25th percentile; 1005 words, 75th percentile], corresponding to two pages. The readability of the RIL, with a median Flesch score of 40 [30; 47], was much poorer than that of pediatric reference texts, with a Flesch score of 67 [60; 73]. A small proportion of RIL (13/91; 14%) were illustrated. The RIL were longer (p<0.001), more readable (p<0.001) and more likely to be illustrated (p<0.009) for industrial than for institutional sponsors. Conclusion: Researchers should routinely compute the reading ease of study information sheets and make greater efforts to improve the readability of written documents for potential participants. © 2011 Menoni et al. Source

Meyzer C.,Unite Of Recherche Clinique Paris Center | Meyzer C.,University of Paris Descartes | Frange P.,University of Paris Descartes | Chappuy H.,Unite Of Recherche Clinique Paris Center | And 12 more authors.
Pediatric Infectious Disease Journal | Year: 2013

BACKGROUND: Vitamin D insufficiency and HIV infection are both risk factors for chronic disorders, so it is important to consider vitamin D status in HIV-infected patients. METHODS: We prospectively investigated serum 25-hydroxyvitamin D (25(OH)D) concentrations, determined by radioimmunoassay, in 113 HIV-infected children (age ≤24 years) and 54 healthy controls matched for age and phototype. We assessed the prevalence of vitamin D deficiency and insufficiency (VDD and VDI) defined as 25(OH)D titers of <10 ng/mL and between 10 and 30 ng/mL, respectively, and their predictive factors. RESULTS: The overall prevalence of VDD and VDI was 38.9% and 58.7%, respectively. Mean serum 25(OH)D concentrations were significantly higher in the HIV group than the control group (14.2 ± 6.9 ng/mL vs. 10.4 ± 5 ng/mL, P < 0.001). Variables significantly associated with low serum 25(OH)D concentrations in HIV-infected children were dark phototype (P < 0.001) and age (r = -0.19, P = 0.03). Patients receiving efavirenz had a trend toward lower serum 25(OH)D concentrations (11.1 ± 4.6 ng/mL vs. 14.6 ± 7 ng/mL, P = 0.1). Dark phototype was the only independent risk factor for VDD in HIV-infected children (odds ratio = 14.6; 95% confidence interval: 2.4-89.9, P = 0.004). CONCLUSIONS: VDD and VDI were common in both HIV-infected and control groups, and serum 25(OH)D concentrations were significantly lower in controls than in HIV-infected children. Copyright © 2013 by Lippincott Williams & Wilkins. Source

Simon A.,Unite dEndocrinologie Pediatrique | Simon A.,University of Paris Descartes | Warszawski J.,French Institute of Health and Medical Research | Warszawski J.,University Paris - Sud | And 16 more authors.
JAMA - Journal of the American Medical Association | Year: 2011

Context: Lopinavir-ritonavir is a human immunodeficiency virus 1 (HIV-1) protease inhibitor boosted by ritonavir, a cytochrome p450 inhibitor. A warning about its tolerance in premature newborns was recently released, and transient elevation of 17-hydroxyprogesterone (17OHP) was noted in 2 newborns treated with lopinavir-ritonavir in France. Objective: To evaluate adrenal function in newborns postnatally treated with lopinavir-ritonavir. Design, Setting, and Participants: Retrospective cross-sectional analysis of the database from the national screening for congenital adrenal hyperplasia (CAH) and the French Perinatal Cohort. Comparison of HIV-1-uninfected newborns postnatally treated with lopinavir-ritonavir and controls treated with standard zidovudine. Main Outcome Measures: Plasma 17OHP and dehydroepiandrosterone-sulfate (DHEA-S) concentrations during the first week of treatment. Clinical and biological symptoms compatible with adrenal deficiency. Results: Of 50 HIV-1-uninfected newbornswhoreceived lopinavir-ritonavir at birth for a median of 30 days (interquartile range [IQR], 25-33), 7 (14%) had elevated 17OHP levels greater than 16.5 ng/mL for term infants (>23.1 ng/mL for preterm) on days 1 to 6 vs 0 of 108 controls having elevated levels. The median 17OHP concentration for 42 term newborns treated with lopinavir-ritonavir was 9.9 ng/mL (IQR, 3.9-14.1 ng/mL) vs 3.7 ng/mL (IQR, 2.6-5.3 ng/mL) for 93 term controls (P<.001). The difference observed in median 17OHP values between treated newborns and controls was higher in children also exposed in utero (11.5 ng/mL vs 3.7 ng/mL; P<.001) than not exposed in utero (6.9 ng/mL vs 3.3 ng/mL; P=.03). The median DHEA-S concentration among 18 term newborns treated with lopinavir-ritonavir was 9242 ng/mL (IQR, 1347-25 986 ng/mL) compared with 484 ng/mL (IQR, 218-1308 ng/mL) among 17 term controls (P<.001). The 17OHP and DHEA-Sconcentrations were positively correlated (r=0.53;P=.001). All term newborns treated with lopinavir-ritonavir were asymptomatic, although 3 premature newborns experienced life-threatening symptoms compatible with adrenal insufficiency, including hyponatremia and hyperkalemia with, in 1 case, cardiogenic shock. All symptoms resolved following completion of the lopinavir-ritonavir treatment. Conclusion: Among newborn children of HIV-1-infected mothers exposed in utero to lopinavir-ritonavir, postnatal treatment with a lopinavir-ritonavir-based regimen,compared with a zidovudine-based regimen, was associated with transient adrenal dysfunction. ©2011 American Medical Association. All rights reserved. Source

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