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1.
Arterioscler Thromb Vasc Biol ; 43(2): e94-e103, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36579650

RESUMO

BACKGROUND: Animal studies have demonstrated that fetal exposure to high maternal cholesterol levels during pregnancy predisposes to aortic atheroma in the offspring. In humans, little is known about the consequences of this exposure on the development of atherosclerotic cardiovascular disease later in life. We wanted to assess whether maternal/paternal inheritance of familial hypercholesterolemia (FH) gene mutation could be associated with subclinical coronary atherosclerosis. METHODS: We retrospectively included 1350 patients, followed in the French registry of FH, with a documented genetic diagnosis. We selected 556 age- and sex-matched pair of patients based on the sex of the parents who transmitted the FH gene mutation, free of coronary cardiovascular event, and with a subclinical coronary atherosclerosis evaluation assessed using coronary artery calcium (CAC) score. We performed univariate and multivariate analysis to assess the individual effect of parental inheritance of the FH gene mutation on the CAC score. RESULTS: In the whole population, patients with maternal inheritance of FH gene mutation (n=639) less frequently had a family history of premature cardiovascular events (27.7% versus 45%, P<0.0001) and were 2 years older (46.9±16.8 versus 44.7±15.9 years old, P=0.02) than those with paternal inheritance (n=711). There was no difference in the prevalence of cardiovascular events between the two groups. In the matched subgroup, maternal inheritance was significantly associated with an increase in CAC score value by 86% (95% CI, 23%-170%; P=0.003), a 1.81-fold risk of having a CAC score ≥100 Agatston units (95% CI, 1.06-3.11; P=0.03), and a 2.72-fold risk of having a CAC score ≥400 Agatston units (95% CI, 1.39-5.51; P=0.004) when compared with paternal inheritance in multivariate analysis. CONCLUSIONS: Maternal inheritance of FH gene mutation was associated with more severe subclinical coronary atherosclerosis assessed by CAC score and may be considered as a potential cardiovascular risk factor.


Assuntos
Aterosclerose , Doença da Artéria Coronariana , Hiperlipoproteinemia Tipo II , Humanos , Adulto , Pessoa de Meia-Idade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/genética , Cálcio , Hiperlipoproteinemia Tipo II/diagnóstico , Hiperlipoproteinemia Tipo II/epidemiologia , Hiperlipoproteinemia Tipo II/genética , Estudos Retrospectivos , Herança Materna , Aterosclerose/epidemiologia , Aterosclerose/genética , Aterosclerose/complicações , Mutação , Fatores de Risco
2.
Br J Clin Pharmacol ; 89(4): 1318-1328, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36680782

RESUMO

Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work on PV. This initiative was put in practice by our Inserm-ANRS MIE PV department in two distinct multinational European consortia with 19 participating countries: conect4children (c4c) for paediatrics research and EU-Response for Covid-19 platform trials. The centralized PV system consists of some key procedures to harmonize the complex safety processes, creation of a local safety officer (LSO) network and centralization of all safety activities. The key procedures described the safety management plan for each trial and how tasks were shared and delegated between all stakeholders. Processing of serious adverse events (SAEs) in a unique database guaranteed the full control of the safety data and continuous evaluation of the risk-benefit ratio. The LSO network participated in efficient regulatory compliance across multiple countries. In total, there were 1312 SAEs in EU-Response and 83 SAEs in c4c in the four trials. We present here the lessons learnt from our experience in four clinical trials. We managed heterogeneous European local requirements and implemented efficient communication with all trial teams. Our approach builds capacity for PV that can be used by multiple academic sponsors.


Assuntos
COVID-19 , Farmacovigilância , Humanos , Criança , Medição de Risco , Bases de Dados Factuais
3.
J Pediatr ; 239: 67-73.e3, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34437911

RESUMO

OBJECTIVE: To capture the early effects of the coronavirus disease 2019 (COVID-19) pandemic on pediatric clinical research. STUDY DESIGN: Pediatric clinical research networks from 20 countries and 50 of their affiliated research sites completed two surveys over one month from early May to early June 2020. Networks liaised with their affiliated sites and contributed to the interpretation of results through pan-European group discussions. Based on first detection dates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), countries formed 1 early detecting and 1 late detecting cluster. We tested the hypothesis that this clustering influenced clinical research. RESULTS: Research sites were first impacted by the pandemic in mid-March 2020 (March 16 ± 10 days, the same date as lockdown initiation; P = .99). From first impact up until early June, site initiation and feasibility analysis processes were affected for >50% of the sites. Staff were redirected to COVID-19 research for 44% of the sites, and 75.5% of sites were involved in pediatric COVID-19 research (only 6.3% reported COVID-19 cases in their other pediatric trials). Mitigation strategies were used differently between the early and late detecting country clusters and between countries with and without a pediatric COVID-19 research taskforce. Positive effects include the development of teleworking capacities. CONCLUSIONS: Through this collaborative effort from pediatric research networks, we found that pediatric trials were affected and conducted with a range of unequally applied mitigations across countries during the pandemic. The global impact might be greater than captured. In a context where clinical research is increasingly multinational, this report reveals the importance of collaboration between national networks.


Assuntos
COVID-19/epidemiologia , Ensaios Clínicos como Assunto/organização & administração , Canadá/epidemiologia , Criança , Europa (Continente)/epidemiologia , Humanos
4.
J Pediatr Gastroenterol Nutr ; 72(3): 343-346, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-32868668

RESUMO

ABSTRACT: Pregnant and lactating women are continuously and ubiquitously exposed to numerous environmental pollutants from various sources including air, food, water, and occupational and household environments. The available evidence shows that pollutants are present in human milk and one of the emerging questions is what happens when the nursing infant is involuntarily exposed to contaminants through breastfeeding.The available literature does not currently provide a conclusive evidence of any consistent or clinically relevant health consequences in infants exposed to environment chemicals through breast milk. The available data strongly suggest that the benefits of breastfeeding outweigh the potential harmful effects of pollutants contained in human milk. The committee of nutrition of the French Pediatric Society strongly supports breastfeeding but also calls for public health actions to reduce the overall contamination level in the environment, to continue promoting breastfeeding, and to support research in this area.


Assuntos
Poluentes Ambientais , Pediatria , Aleitamento Materno , Criança , Poluentes Ambientais/análise , Poluentes Ambientais/toxicidade , Feminino , Humanos , Lactente , Lactação , Leite Humano/química , Gravidez , Saúde Pública
5.
Appetite ; 136: 25-32, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30641157

RESUMO

INTRODUCTION: The exact mechanisms underlying the established association between ADHD and obesity remain unclear. Food addiction and binge eating may contribute to this link. We examined for the first time the association between childhood/adult ADHD and food addiction/binge eating in patients with obesity, as well as the association between ADHD and sleep apnea syndrome. METHODS: We included 105 obese patients from the Nutrition Department of the University Hospital of Tours (France) between January and December 2014. We assessed categorical diagnoses of childhood/adulthood ADHD (semi-structured interview DIVA 2.0), food addiction (Yale Food Addiction Scale 2.0), binge eating (Binge Eating Scale), obstructive sleep apnea (clinical assessment), and BMI (clinical assessment). RESULTS: Patients with adult ADHD were at significantly higher risk of food addiction than patients without adult ADHD (28.6% vs. 9.1%; p = .016). Adult and childhood ADHD were significantly associated with self-reported food addiction, food addiction scores and binge eating scores, with a larger effect size for adult (ORs: 4.00 [1.29-12.40], 1.37 [1.14-1.65] and 1.08 [1.03-1.14], respectively) than childhood (ORs: 3.32 [1.08-10.23], 1.29 [1.08-1.55] and 1.06 [1.01-1.11], respectively) ADHD. ADHD diagnosis was not significantly correlated to obstructive sleep apnea. Mean age of onset of ADHD preceded mean age of onset of obesity. CONCLUSION: ADHD diagnosis is associated with food addiction and binge eating, with a larger effect size for adult than childhood ADHD. Our results provide a strong rationale for further longitudinal research on the link between ADHD, food addiction, binge eating and obesity, paving the way for evidence-based therapeutic interventions for these patients.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/epidemiologia , Bulimia/epidemiologia , Dependência de Alimentos/epidemiologia , Obesidade/epidemiologia , Síndromes da Apneia do Sono/epidemiologia , Adulto , Idade de Início , Idoso , Comorbidade , Estudos Transversais , Feminino , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade
6.
7.
Public Health Nutr ; 21(3): 502-514, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29094670

RESUMO

OBJECTIVE: To update the data on food consumption and practices in children under 3 years of age in metropolitan France. DESIGN: The Nutri-Bébé 2013 cross-sectional study selected a random sample, according to the quota sampling method. After giving their informed consent, parents had to record the food consumption during three non-consecutive days framed by two face-to-face interviews, using for quantitative information different portion size measurement aids. RESULTS: One thousand one hundred and eighty-four children were enrolled. Mothers' mean age was 30·8 (sd 5·4) years; 38 % were primiparous; 89 % lived with a partner; 60 % had an occupation. Of the infants younger than 4 months, 31 % were breast-fed. One thousand and thirty-five children consumed infant formula followed by growing-up milk in 63 % of them; solid foods were introduced at a mean age of 5·4 (sd 2·13) months. From 8 months onwards, 25 % of children consumed the same foods as their parents on a more or less regular basis; 29 % ate in front of a screen, with a daily average screen time of 43·0 (sd 40·4) min. CONCLUSIONS: This robust survey highlights the low prevalence and duration of breast-feeding in France and shows a modest improvement since the previous survey of 2005 in the observance of recommendations concerning other feeding practices. The frequent consumption of adult foods and the screen time are of concern.


Assuntos
Alimentação com Mamadeira , Aleitamento Materno , Dieta , Alimentos Infantis , Fórmulas Infantis , Adulto , Fatores Etários , Animais , Alimentação com Mamadeira/estatística & dados numéricos , Aleitamento Materno/estatística & dados numéricos , Pré-Escolar , Estudos Transversais , Feminino , França , Humanos , Lactente , Recém-Nascido , Masculino , Leite , Ocupações , Pais , Tempo de Tela , Parceiros Sexuais , Inquéritos e Questionários , Desmame
8.
Eur J Anaesthesiol ; 34(8): 544-549, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28682815

RESUMO

BACKGROUND: Malnutrition is often underdiagnosed in hospitalised children, although it is associated with postoperative complications, longer hospital lengths of stay and increased healthcare-related costs. OBJECTIVE: We aimed to estimate the frequency of, and identify factors associated with, malnutrition in children undergoing anaesthesia. DESIGN: Cross-sectional observational study. SETTING: Paediatric anaesthesia department at the University Children's Hospital, Bordeaux, France. PARTICIPANTS: A total of 985 patients aged less than 18 years. MAIN OUTCOME MEASURES: Anthropometric measurements, American Society of Anesthesiologists physical status classification score and the Pediatric Nutritional Risk Score (PNRS) recorded at the pre-anaesthesia evaluation. RESULTS: When assessed as a Waterlow index less than 80%, malnutrition was present in 7.6% children. This increased to 8.1% of children assessed by clinical signs and to 11% of children when defined by a BMI less than the third percentile. In a univariate analysis, children with a BMI less than the third percentile were more often born prematurely (22.4 vs 10.4%; P = 0.0008), were small for gestational age at birth (18.4 vs 4.5%; P < 0.0001), were admitted from the emergency department (12.0 vs 5.6%; P = 0.02), had a high American Society of Anesthesiologists score (P < 0.0001), or had a high Pediatric Nutritional Risk Score (P < 0.0001). Presence (P = 0.01) and type (P = 0.002) of chronic disease were also associated with malnutrition. In the multivariate analysis, a premature birth, a lower birth weight and a higher Pediatric Nutritional Risk Score were significantly associated with a higher odds of malnutrition when defined by BMI. CONCLUSION: All children should be screened routinely for malnutrition or the risk of malnutrition at the pre-anaesthesia visit, allowing a programme of preoperative and/or postoperative nutritional support to be initiated. We suggest that as well as weight and height, BMI and a pediatric nutritional risk score such as PNRS should be recorded routinely at the pre-anaesthesia visit.


Assuntos
Anestesia Geral/tendências , Transtornos da Nutrição Infantil/diagnóstico , Transtornos da Nutrição Infantil/epidemiologia , Hospitais Universitários/tendências , Recém-Nascido de Baixo Peso/fisiologia , Recém-Nascido Prematuro/fisiologia , Anestesia Geral/efeitos adversos , Criança , Transtornos da Nutrição Infantil/fisiopatologia , Pré-Escolar , Estudos Transversais , Feminino , França/epidemiologia , Humanos , Lactente , Masculino , Fatores de Risco
9.
Am J Med Genet A ; 170A(5): 1358-62, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26872355

RESUMO

Protein-energy malnutrition (PEM) is poorly reported in cri du chat syndrome (CDCS) (OMIM #123450), a genetic disease that causes developmental delay and global growth retardation. The objective was to determine the nutritional status at different ages in children with CDCS and factors associated with PEM. A questionnaire focused on growth and nutritional care was sent to 190 families. Among 36 analyzable questionnaires, growth and nutritional indices compatible with PEM occurred in 47% of patients: 19% before 6 months of age, 24% between 6-12 months and 34% after 12 months. Eight patients received enteral feeding. Speech therapy for swallowing education was performed more often in malnourished children (63% vs. 22%, P < 0.02). PEM is frequent and occurs early in this disease, requiring closed nutritional monitoring.


Assuntos
Síndrome de Cri-du-Chat/fisiopatologia , Estado Nutricional , Desnutrição Proteico-Calórica/fisiopatologia , Pré-Escolar , Síndrome de Cri-du-Chat/complicações , Síndrome de Cri-du-Chat/genética , Feminino , Humanos , Lactente , Masculino , Desnutrição Proteico-Calórica/complicações , Desnutrição Proteico-Calórica/genética , Inquéritos e Questionários
11.
Matern Child Nutr ; 10(2): 267-79, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22642271

RESUMO

The wide variety of infant formula available on the market can be confusing for parents and physicians. We aimed to determine associations between predominant type of formula used from birth to 4 months and parental and child characteristics and type of physician consulted, and then to describe relations between type of formula used and growth. Our analyses included 1349 infants from the EDEN mother-child cohort. Infant's feeding mode and type of formula used were assessed at 4 months by maternal self-report. Infant's weight and height from birth to 4 months, measured in routine follow-up, were documented by health professionals in the infant's personal health record. Anthropometric z-scores were calculated by using World Health Organization growth standards. Multinomial logistic regression was used to identify factors associated with the type of formula predominantly used; relations with growth were analysed by linear regressions. Partially hydrolysed formulas were more likely to be used by primiparous women (P < 0.001), those breastfeeding longer (P < 0.001) and for infants with family history of allergies (P = 0.002). Thickened formulas were more often used by mothers returning to employment in the first 4 months (P = 0.05) and breastfeeding shortly (P < 0.001). No significant relation was found between infant's growth and type of formula (P > 0.20). Infants breastfed shorter showed higher weight-for-age (P < 0.001) and length-for-age (P = 0.001) z-score changes between birth and 4 months. The use of a specific type of infant formula seems to be mainly related to parental characteristics. Infant's growth in the first 4 months is related to other factors than to the type of formula used.


Assuntos
Desenvolvimento Infantil/fisiologia , Fórmulas Infantis/administração & dosagem , Fenômenos Fisiológicos da Nutrição do Lactente , Adolescente , Adulto , Aleitamento Materno , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Modelos Lineares , Modelos Logísticos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Paridade , Gravidez , Estudos Prospectivos , Fatores Socioeconômicos , Adulto Jovem
12.
Amino Acids ; 45(6): 1365-72, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24072506

RESUMO

Since exclusively breast-suckled infants obtain their nutrient only from their mother's milk, it might be anticipated that a correlation will exist between the (15)N/(14)N isotope ratios of amino acids of protein of young infants and those supplied by their mother. The work presented here aimed to determine whether amino nitrogen transfer from human milk to infant hair protein synthesized within the first month of life conserves the maternal isotopic signature or whether post-ingestion fractionation dominates the nitrogen isotope spectrum. The study was conducted at 1 month post-birth on 100 mother-infant pairs. Isotope ratios (15)N/(14)N and (13)C/(12)C were measured using isotope ratio measurement by Mass Spectrometry (irm-MS) for whole maternal milk, and infant hair and (15)N/(14)N ratios were also measured by GC-irm-MS for the N-pivaloyl-O-isopropyl esters of amino acids obtained from the hydrolysis of milk and hair proteins. The δ(15)N and δ(13)C (‰) were found to be significantly higher in infant hair than in breast milk (δ(15)N, P < 0.001; δ(13)C, P < 0.001). Furthermore, the δ(15)N (‰) of individual amino acids in infant hair was also significantly higher than that in maternal milk (P < 0.001). By calculation, the observed shift in isotope ratio was shown not to be accounted for by the amino acid composition of hair and milk proteins, indicating that it is not simply due to differences in the composition in the proteins present. Rather, it would appear that each pool-mother and infant-turns over independently, and that fractionation in infant N-metabolism even in the first month of life dominates over the nutrient N-content.


Assuntos
Aminoácidos/análise , Cabelo/química , Proteínas do Leite/química , Leite Humano/química , Adulto , Feminino , Humanos , Lactente , Isótopos de Nitrogênio/análise
13.
Rapid Commun Mass Spectrom ; 27(12): 1345-53, 2013 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-23681812

RESUMO

RATIONALE: In isotope tracer experiments used in nutritional studies, it is frequently desirable both to determine the (15)N/(14)N ratios of target compounds and to quantify these compounds. This report shows how this can be achieved in a single chromatographic run for protein amino acids using an isotope ratio mass spectrometer. METHODS: Protein hydrolysis by acidic digestion was used to release amino acids, which were then derivatized as their N-pivaloyl-O-isopropyl esters. Suitable conditions for sample preparation were established for both hair and milk proteins. The N-pivaloyl-O-isopropyl esters of amino acids were separated by gas chromatography (GC) on a 60 m ZB-WAX column linked via a combustion interface to an isotope ratio mass spectrometer. The (15)N/(14)N ratios were obtained from the m/z 28, 29 and 30 peak intensities and the quantities from the Area All (Vs) integrated peak areas. RESULTS: It is shown from a five-point calibration curve that both parameters can be measured reliably within the range of 1.0 to 2.0 mg/mL for the major amino acids derived from the hydrolysis of human maternal milk or hair samples. The method was validated in terms of inter-day and inter-user repeatability for both parameters for 14 amino acids. The amino acid percentage composition showed a good correlation with literature values. The method was applied to determine the variability in a population of lactating mothers and their infants. CONCLUSIONS: It has been established that δ(15)N values can be simultaneously determined for a complex mixture of amino acids at variable concentrations. It is shown that the percentage composition obtained correlates well with that obtained by calculation from the protein composition or from literature values. This procedure should provide a significant saving in analysis time, especially in those cases where the GC run-time is necessarily long. It allows the satisfactory determination of the variation within a sample population.


Assuntos
Aminoácidos/análise , Cromatografia Gasosa-Espectrometria de Massas/métodos , Cabelo/química , Leite Humano/química , Isótopos de Nitrogênio/análise , Proteínas/química , Adulto , Feminino , Humanos , Lactente , Lactação , Masculino , Adulto Jovem
14.
Arch Pediatr ; 30(7): 517-520, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37394365

RESUMO

The aim of our study was to assess the nutritional status of hospitalized children with cystic fibrosis. We extracted data from the ePINUT surveys. Undernutrition was defined as a body mass index (BMI) of <18.5 according to the International Obesity Task Force cut-off, and the nutritional status goal was defined as a BMI z-score ≥0 SD for children older than 2 years and a weight-for-height z-score ≥0 SD for those younger than 2 years. Undernutrition frequency in the 114 patients with cystic fibrosis was 46% and was higher than in children with other chronic diseases (n = 5863; 30.5%; p = 0.001); 81% of children were below the nutritional status goal. Undernutrition frequency in cystic fibrosis is higher than in other chronic diseases.


Assuntos
Fibrose Cística , Desnutrição , Criança , Humanos , Pré-Escolar , Criança Hospitalizada , Fibrose Cística/complicações , Fibrose Cística/epidemiologia , Desnutrição/epidemiologia , Desnutrição/etiologia , Estado Nutricional , Índice de Massa Corporal , Doença Crônica
15.
Arch Pediatr ; 30(1): 36-41, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36473753

RESUMO

In 2019, the French National Authority for Health (Haute Autorité de Santé, HAS) published guidelines on the diagnosis of undernutrition. The present article focuses on the impact of switching from the 2012 guidelines of the Nutrition Committee of the French Paediatric Society (CNSFP) to the HAS guidelines on the frequency of hospital undernutrition in children. We selected for the period 2010-2019 from the ePINUT database: (1) all children aged more than 2 years with (2) clinically confirmed nutritional status in (3) French sites. The frequency of undernutrition was 15.4% vs. 28.8% using the CNSFP and HAS criteria, respectively (p < 0.01; n = 6304). When compared to non-malnourished children regardless of the criteria used, malnourished children: (1) stayed longer in hospital (CNSFP: 9.0 ±â€¯11.8 vs. 6.5 ±â€¯8.7 days, p < 0.01; HAS: 7.8 ±â€¯10.1 vs. 6.4 ±â€¯8.4 days, p < 0.01), (2) gained more weight during hospitalization (% of weight at admission) (CNSFP: +1.4 ±â€¯4.1 vs. -0.3 ±â€¯3.5%, p < 0.01; HAS: +2.3 ±â€¯4.7 vs. -0.1 ±â€¯3.4%, p < 0.01), and (3) received nutritional support more frequently during hospitalization (CNSFP: 20% vs. 5%, p < 0.01; HAS: 13% vs. 4%, p < 0.01). Switching to the HAS guidelines resulted in an almost twofold higher frequency of undernutrition in hospitalized children. Initiation of nutritional care remained low considering the nutritional status. The present study warrants interventional studies to determine which children may benefit more from nutritional therapy to improve their outcome.


Assuntos
Desnutrição , Criança , Humanos , Desnutrição/diagnóstico , Desnutrição/epidemiologia , Estado Nutricional , Hospitalização , Apoio Nutricional , Hospitais , Avaliação Nutricional
16.
Therapie ; 78(1): 105-114, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36528416

RESUMO

Despite various international regulatory initiatives over the last 20 years, many challenges remain in the field of paediatric drug development and evaluation. Indeed, drug research and development is still focused essentially on adult indications, thereby excluding many paediatric patients, limiting the feasibility of trials and favouring competing developments. Off-label prescribing persists and the development of age-appropriate dosage forms for children remains limited. Against this background, the members of this panel (TR) recommend the launch of multi-partner exchange forums on specific topics in order to focus new drug research and development on the real, unmet medical needs of children and adolescents, and in keeping with the underlying mechanisms of action. Scientific information sharing and cooperation between stakeholders are also essential for defining reference evaluation methods in each medical field. These forums can be organised through existing paediatric facilities and research networks at the French and European level. The latter are specifically dedicated to paediatric research and can facilitate clinical trial implementation and patient enrolment. Moreover, specific grants and public/private partnerships are still needed to support studies on the repositioning of drugs in paediatric indications, and pharmacokinetic studies aimed at defining appropriate dosages. The development of new pharmaceutical forms, better suited for paediatric use, and the promotion of resulting innovations will stimulate future investments. Initiatives to gather observational safety and efficacy data following off-label and/or derogatory early access should also be encouraged to compensate for the lack of information available in these situations. Finally, the creation of Ethics Committees (EC) with a specific "mother-child" advisory expertise should be promoted to ensure that the current regulation (Jardé law in France) is implemented whilst also taking into account the paediatric specificities in medical trials.


Assuntos
Desenvolvimento de Medicamentos , Adolescente , Adulto , Criança , Humanos , França , Previsões
17.
Pediatr Res ; 71(5): 598-604, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22398698

RESUMO

INTRODUCTION: Protein intake in fetal life or infancy may play a key role in determining early growth rate, a determinant of later health and disease. Previous work has indicated that hair isotopic composition is influenced by diet and protein intake. METHODS: This study analyzes the isotopic composition of hair obtained from 239 mother/newborn pairs randomly selected within a larger cohort enrolled in a study of pre- and postnatal determinants of the child's development and health. The isotopic compositions in nitrogen (δ(15)N) and in carbon (δ(13)C) were determined by isotope ratio mass spectrometry. RESULTS: Mother and newborn hair δ(15)N were tightly correlated (Pearson r = 0.88). The mean δ(15)N and δ(13)C values of hair from newborn infants were significantly higher than those for the mothers: 9.7 ± 0.7 vs. 8.8 ± 0.6‰ (P < 0.0001) for δ(15)N and -20.0 ± 0.4 vs. -20.4 ± 0.4‰ (P < 0.0001) for δ(13)C. Maternal hair δ(15)N at parturition was slightly and positively correlated with estimates of protein intake (r = 0.14, P = 0.04). DISCUSSION: Hair δ(15)N of the fetus is both highly dependent on and systematically higher than that of the mother. Whether quantitative and qualitative protein intake, disease, or hormonal status alter hair δ(15)N at birth remains to be determined.


Assuntos
Isótopos de Carbono/análise , Cabelo/química , Isótopos de Nitrogênio/análise , Adulto , Estudos de Coortes , Feminino , Humanos , Recém-Nascido , Masculino , Espectrometria de Massas
18.
Metabolites ; 12(10)2022 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-36295801

RESUMO

While clinical evidence remains limited, an extensive amount of research suggests a beneficial role of n-3 polyunsaturated fatty acid supplementation in cancer treatment. One potential benefit is an improvement of protein homeostasis, but how protein metabolism depends on proinflammatory cytokines in this context remains unclear. Here, using the natural abundance of the stable isotopes of nitrogen as a marker of changes in protein metabolism during a randomized, double-blind, controlled clinical trial, we show that protein homeostasis is affected way faster than proinflammatory cytokines in metastatic breast cancer patients supplemented with n-3 polyunsaturated fatty acids. We provide some evidence that this response is unrelated to major changes in whole-body substrate oxidation. In addition, we demonstrate that more fatty acids were impacted by metabolic regulations than by differences in their intake levels during the supplementation. This study documents that the percentage of patients that complied with the supplementation decreased with time, making compliance assessment crucial for the kinetic analysis of the metabolic and inflammatory responses. Our results highlight the time-dependent nature of metabolic and inflammatory changes during long-chain n-3 fatty acid supplementation.

19.
Clin Nutr ; 41(7): 1613-1618, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35637040

RESUMO

We have previously advocated that nutritional care be raised to the level of a human right in a close relationship to two well recognized fundamental rights: the right to food and the right to health. This paper aims to analyze the implication of nutritional care as a human right for healthcare practitioners. We will focus on the impact of the Human Rights Basic Approach (HRBA) on health care professionals (HCPs), namely how they can translate HRBA into routine clinical practice. Ethics and human rights are guiding values for clinical nutrition practitioners. Together they ensure a patient-centered approach, where the needs and rights of the patients are of the most significant importance. Human rights are based on the powerful idea of equal dignity for all people while expressing a set of core values, including fairness, respect, equality, dignity, and autonomy (FREDA). Through the analysis of FREDA principles, we have provided the elements to understand human rights and how a HRBA can support clinicians in the decision-making process. Clinical practice guidelines in clinical nutrition should incorporate disease-specific ethical issues and the HRBA. The HRBA should contribute to build conditions for HCPs to provide optimal and timely nutritional care. Nutritional care must be exercised by HCPs with due respect for several fundamental ethical values: attentiveness, responsibility competence, responsiveness, and solidarity.


Assuntos
Direitos Humanos , Humanos
20.
Nutr Clin Pract ; 37(4): 743-751, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35599586

RESUMO

We have previously advocated that nutritional care be raised to the level of a human right, in close relationship to two well-recognized fundamental rights: the right to food and the right to health. This article aims to analyze the implication of nutritional care as a human right for healthcare practitioners. We will focus on the impact of the Human Rights Basic Approach (HRBA) on healthcare professionals (HCPs), namely how they can translate HRBA into routine clinical practice. Ethics and human rights are guiding values for clinical nutrition practitioners. Together they ensure a patient-centered approach, in which the needs and rights of the patients are of the most significant importance. Human rights are based on the powerful idea of equal dignity for all people while expressing a set of core values, including fairness, respect, equality, dignity, and autonomy (FREDA). Through the analysis of FREDA principles, we have provided the elements to understand human rights and how an HRBA can support clinicians in the decision-making process. Clinical practice guidelines in clinical nutrition should incorporate disease-specific ethical issues and the HRBA. The HRBA should contribute to building conditions for HCPs to provide optimal and timely nutritional care. Nutritional care must be exercised by HCPs with due respect for several fundamental ethical values: attentiveness, responsibility competence, responsiveness, and solidarity.


Assuntos
Direitos Humanos , Humanos
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