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1. Review highlights the importance of donor human milk being available for very low birth weight infants

Author

Team1 Carmen, Carmen Lab, ROSSI, Sabine, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)

Subjects
digestive malformations, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, Milk, Human, breastfeeding, prematurity, Infant, Newborn, Infant, Infant, Premature, Diseases, General Medicine, congenital heart disease, Infant Formula, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, Pediatrics, Perinatology and Child Health, Humans, Infant, Very Low Birth Weight, necrotising enterocolitis, Infant Nutritional Physiological Phenomena, Infant, Premature
Abstract

International audience; Aim The aim of this paper was to review the role that donor human milk plays in caring for very low birth weight (VLBW) infants. Methods This review focussed on academic papers and background information published in English and French up to 8 August 2021. Results Donor human milk provides a useful bridge to successful breastfeeding in hospitalised neonates and does not have a negative impact on the use of mother's own milk and breastfeeding rates at discharge. It helps to prevent key complications of prematurity, particularly necrotising enterocolitis up to 36 weeks of postmenstrual age, which is more common in infants fed formulas based on cows' milk. When it is carefully fortified, it supports the postnatal growth of the majority of very preterm infants. Well-organised, accessible human milk banks are required to cover the needs of hospitalised infants, and donor human milk must be prioritised for patients who derive the greatest health benefit from it. These include very preterm infants and those born at term, or near term, with surgical digestive malformations or congenital heart disease. Conclusion Safe, high-quality donor human milk, which is distributed by well-organised human milk banks, is essential for the most vulnerable hospitalised neonates.

Published
2022

2. Dissemination of newborn behavior observation skills after Newborn Individualized Developmental Care and Assessment Program (NIDCAP) implementation

Author

Sabine Durand, Nicolas Nagot, Laurence Chandebois, Florence Masson, Gilles Cambonie, Erika Nogue, Catherine Bouschbacher, Renaud Mesnage, BONIZEC, Sandrine, Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), Pathogenesis and Control of Chronic and Emerging Infections (PCCEI), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Université des Antilles (UA)-Etablissement français du don du sang [Montpellier]

Subjects
Newborn Individualized Developmental Care and Assessment Program (NIDCAP), medicine.medical_specialty, media_common.quotation_subject, [SHS.EDU]Humanities and Social Sciences/Education, [SHS.EDU] Humanities and Social Sciences/Education, education, nurse, RT1-120, staff development, Certification, Nursing, Patient care, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, Developmental care, medicine, Humans, Quality (business), Neonatology, Video technology, neonatal care, Research Articles, General Nursing, media_common, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, business.industry, Professional development, Infant, Newborn, infant behaviour, premature infant, nurses–patient interaction, video technology, advanced practice, Observational study, business, Behavior Observation Techniques, Infant, Premature, Research Article
Abstract

International audience; Aim: To assess nurses’ ability to observe newborn behaviour after in situ training provided by caregivers with advanced practice certification in the Newborn Individualized Developmental Care and Assessment Program (NIDCAP).Design: Prospective observational study.Methods: Twelve nurses viewed 20-min films showing the behaviour of 10 premature newborns before, during and after the usual caregiving. The behaviour was rated on an observation sheet with 88 items distributed into six systems. The responses were compared to the reference ratings established by two professionals certified for this programme.Results: Despite less accurate observations during care and for some components, the nurses generally showed a satisfactory ability to observe newborn behaviour after training by NIDCAP expert professionals. The dissemination of observation skills among caregivers may result in an improved quality of patient care and better communication among professionals in a department of neonatology.

Published
2021

3. Faecal calprotectin and gut microbiota do not predict enteropathy in very preterm infants

Author

Marie de Stefano, Ponny Gobalakichenane, Marie-José Butel, Florence Campeotto, Nathalie Kapel, Caroline Elie, T Hachem, Clotilde Rousseau, Mathilde Le Touzey, A Giuséppi, CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Physiopathologie et pharmacotoxicologie placentaire humaine : Microbiote pré & post natal (3PHM - UMR-S 1139), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Service de microbiologie [Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP), Service de néonatologie [CHU Trousseau], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHI Poissy-Saint-Germain, CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Gestionnaire, Hal Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), CHU Trousseau [APHP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
faecal calprotectin, Gut flora, Enteral administration, Gastroenterology, Feces, fluids and secretions, 0302 clinical medicine, Pregnancy, RNA, Ribosomal, 16S, Enteropathy, Prospective Studies, 030212 general & internal medicine, biology, Gestational age, Regular Article, General Medicine, 3. Good health, Premature Birth, Female, necrotising enterocolitis, Infant, Premature, medicine.medical_specialty, preterm neonates, 03 medical and health sciences, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, 030225 pediatrics, Internal medicine, medicine, Humans, Very Preterm Birth, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, gut microbiota, business.industry, Infant, Newborn, Infant, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, medicine.disease, biology.organism_classification, Faecal calprotectin, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Gastrointestinal Microbiome, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, enteropathy, Pediatrics, Perinatology and Child Health, Regular Articles & Brief Reports, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Neonatology, Calprotectin, business, Leukocyte L1 Antigen Complex
Abstract

International audience; Aim: Very preterm birth is associated with a high risk of enteropathies. Diagnosis is challenging, especially in mild forms, leading to unnecessary periods of cessation of enteral feeding. This study aimed at establishing a prognosis score of enteropathy combining clinical parameters and faecal calprotectin concentration.Methods: This prospective multicentric study included preterm neonates born at a gestational age of 33 weeks or less. Stools were collected weekly until hospital discharge, and daily in case of digestive events for calprotectin measurement (ELISA and immunochromatography) and microbiota analyses (16S rRNA gene sequencing).Results: Among the 121 neonates included, 21 experienced at least one episode of enteropathy, mainly mild forms. By ELISA testing, median faecal calprotectin was 88 (8-798) µg/g faeces. No statistically significant association was found between the outset of enteropathy and maternal and neonatal characteristics, and calprotectin levels. The agreement between ELISA and immunochromatography assay was moderate (intra-class correlation coefficient 0.58, 95%CI [0.47-0.66]). Comparison of species diversity and relative bacterial abundance profiles between infants with or without enteropathy revealed no specific alterations associated with enteropathy.Conclusion: The study failed to propose a prognostic score of enteropathy, probably due the large inter- and intra-individual variability of faecal calprotectin in very preterm neonates.

Published
2020

4. Quality of life in children with severe forms of idiopathic nephrotic syndrome in stable remission—A cross‐sectional study

Author

Stéphane Decramer, Georges Deschênes, Laurianne Micheland, Jean-Daniel Delbet, Tim Ulinski, Aphaia Roussel, Gestionnaire, Hal Sorbonne Université, Service de néphrologie et pédiatrie générale [CHU Trousseau], CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Departement Hospitalo- Universitaire - Inflammation, Immunopathologie, Biothérapie [Paris] (DHU - I2B), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Equipe 2 : ECSTRA - Epidémiologie Clinique, STatistique, pour la Recherche en Santé (CRESS - U1153), Université Paris Diderot - Paris 7 (UPD7)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP Hôpital universitaire Robert-Debré [Paris], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-CHU Saint-Antoine [AP-HP], and Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)

Subjects
Male, medicine.medical_specialty, Adolescent, Cross-sectional study, medicine.medical_treatment, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, 03 medical and health sciences, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, 0302 clinical medicine, Quality of life, 030225 pediatrics, Internal medicine, Humans, Medicine, 030212 general & internal medicine, Child, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, immunosuppression, nephrotic syndrome, business.industry, Immunosuppression, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, General Medicine, medicine.disease, [SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, 3. Good health, Cross-Sectional Studies, quality of life, children and adolescents, Intravenous therapy, Pediatrics, Perinatology and Child Health, Population study, Female, Observational study, Rituximab, [SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy, business, Nephrotic syndrome, Immunosuppressive Agents, medicine.drug
Abstract

International audience; AIM: Severe forms of idiopathic nephrotic syndrome (INS) require immunosuppressive therapy: oral treatment or intravenous therapy (rituximab, RTX). The main objective was to describe quality of life (QOL) in these specific patients.METHODS: Cross-sectional, multicentre, observational study analysed QOL using a standardised questionnaire in children from 7 to 17 years, with a steroid-dependent or steroid-resistant INS in stable remission. The questionnaire consisted of 30 questions concerning physical and emotional well-being, self-esteem, family, friends, school and disease resulting in a global score of 0-100.RESULTS: A total of 110 patients with a mean age of 11.6 years from three French paediatric nephrology centres were included. A total of 71 patients had oral immunosuppressive treatment, 27 had RTX, and 12 had both. 13.6% of patients had a steroid-resistant INS. The mean number of relapses was 5.8. Seventy-eight patients answered the questionnaire. The global score in the whole study population was 74.7; 72.6 in the RTX group, 76.2 in the oral drugs group, (P = 0.49). The results of sub-dimension 'school' were statistically lower in RTX group (61.6 ± 19.5) compared with oral drugs group (71.4 ± 16; P = 0.02).CONCLUSION: Global QOL score was high in 'difficult-to-treat' patients with INS in stable remission on oral immunosuppressive or RTX treatment.

Published
2019

5. Interactions between eye movements and posture in children with neurodevelopmental disorders

Author

Hugo Peyre, Christophe-Loïc Gerard, Coline Stordeur, Richard Delorme, Delphine Dehouck, Nathalie Goulème, Maria Pia Bucci, Aline Lefebvre, Mathilde Septier, Eric Acquaviva, HAL Nanterre, Administrateur, Hôpital Robert Debré, Maladies neurodéveloppementales et neurovasculaires (NeuroDiderot (UMR_S_1141 / U1141)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Hôpital Robert Debré Paris

Subjects
Male, medicine.medical_specialty, Eye Movements, Audiology, Sitting, behavioral disciplines and activities, 050105 experimental psychology, Task (project management), Dyslexia, 03 medical and health sciences, Ocular Motility Disorders, Autistic Spectrum Disorder, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, 0302 clinical medicine, Developmental Neuroscience, Cerebellum, Reaction Time, medicine, Humans, ADHD, 0501 psychology and cognitive sciences, Spectrum disorder, [SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Child, Postural Balance, Intelligence Tests, Analysis of Variance, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, 05 social sciences, Eye movement, medicine.disease, High-functioning autism, Postural Control, Neurodevelopmental Disorders, Case-Control Studies, Sensation Disorders, Saccade, Fixation (visual), Female, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Psychology, Photic Stimulation, psychological phenomena and processes, 030217 neurology & neurosurgery, Developmental Biology
Abstract

International audience; In everyday life, our activities frequently involve the simultaneous performance of two or more tasks. Sharing attention between two concurrent tasks may result in a decrease in performance specifically among children with neurodevelopmental disorders. The objective of the study was to determine whether the influence of postural conditions (sitting condition, single task; standing condition, dual task) on eye movement performances on three visual tasks with high attentional load (visually-guided saccade task, memory-guided saccade task and fixation task) was different in children with neurodevelopmental disorders (attention deficit and hyperactive disorder, dyslexia, and high functioning autism spectrum disorder) when compared to typically developing children. One hundred and four children (26 per group, sex-age-and IQ-matched groups) were evaluated. We found that for the fixation task only, the three groups of children with neurodevelopmental disorders had poorer eye movements performances in the standing condition compared to the sitting condition while no such difference was found for typically developing children. We suggest that children with neurodevelopmental disorders have fewer attentional resources available for performing correctly oculomotor tasks with high atten-tional load leading to impairment of these tasks for maintaining a good level of postural stability.

Published
2018

6. Unexpected benefits of the COVID challenge: When critically ill adult patients are managed in a pediatric PACU

Author

Yael Levy, Nada Sabourdin, Nicolas Louvet, Sarah Chemam, Marie-Pierre Bonnet, Isabelle Constant, Service de réanimation néonatale et pédiatrique [CHU Trousseau], CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Service d'anesthésie-réanimation [CHU Trousseau], Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Lallemant, Christopher

Subjects
Adult, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Critical Illness, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), MEDLINE, 030204 cardiovascular system & hematology, Pacu, 03 medical and health sciences, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, 0302 clinical medicine, Correspondence, Humans, Medicine, 030212 general & internal medicine, Pediatrics, Perinatology, and Child Health, Child, Intensive care medicine, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, biology, Adult patients, SARS-CoV-2, business.industry, Critically ill, COVID-19, biology.organism_classification, 3. Good health, Anesthesiology and Pain Medicine, Pediatrics, Perinatology and Child Health, business
Abstract

International audience

Published
2020
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7. Allergen Immunotherapy (AIT) in children: a vulnerable population with its own rights and legislation – summary of EMA-initiated multi-stakeholder meeting on Allergen Immunotherapy (AIT) for children, held at Paul-Ehrlich-Institut, Langen, Germany, 16.1.2019

Author

Andreas Bonertz, S. Vieths, Jean Bousquet, Vera Mahler, Philippe Eigenmann, S. Kaul, Oliver Pfaar, Ulrich Wahn, D. Mentzer, Antonella Muraro, Marek Jutel, Susanne Halken, Paul-Ehrlich-Institute - Federal Institute for Vaccines and Biomedicines (EPI), Azienda Ospedale Università di Padova = Hospital-University of Padua (AOUP), Hôpitaux Universitaires de Genève (HUG), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], University of Southern Denmark (SDU), Odense University Hospital (OUH), Philipps Universität Marburg = Philipps University of Marburg, University of Wrocław [Poland] (UWr), and Retiveau, Nolwenn

Subjects
Pulmonary and Respiratory Medicine, Allergen immunotherapy, Allergy, medicine.medical_specialty, Paediatric Committee (PDCO), Therapy Allergen Ordinance (TAO), Immunology, Legislation, Review, Disease, Paediatric Investigation Plan (PIP), 030207 dermatology & venereal diseases, 03 medical and health sciences, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, 0302 clinical medicine, Agency (sociology), medicine, Immunology and Allergy, Vulnerable population, [SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology, Children, Asthma, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, business.industry, European Medicines Agency (EMA), [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, RC581-607, Allergie, Allergen Immunotherapy (AIT), medicine.disease, Incentive, 030228 respiratory system, Family medicine, Immunologic diseases. Allergy, [SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy, business, [SDV.IMM.ALL] Life Sciences [q-bio]/Immunology/Allergology
Abstract

International audience; Concerning development of medicinal products, children belong to a so-called "special population" for which additional legislation applies: Regulation (EC) No 1901/2006 on medicinal products for paediatric use sets up a system of requirements, rewards and incentives to ensure that medicinal products are researched, developed and authorized to meet the therapeutic needs of children. Allergen Immunotherapy (AIT) is believed to contain a strong potential for immunomodulatory effects inducing sustained clinical efficacy after cessation of treatment (disease modifying effect) and thereby may prevent the progression of the atopic march towards asthma manifestation. However, to this day only few data on long-term effects in general exist and even fewer in children. These are predominantly data from open studies, which are strongly influenced in their validity by the known placebo effect of AIT. Furthermore, there are no studies allowing for the conclusion that efficacy in adults are mirrored by a similar efficacy in children and thus, up to now, it is not possible to extrapolate data from adults to children. The Paediatric Committee (PDCO)-European Medicines Agency's (EMA) scientific committee responsible for activities on medicines for children-initiated a Multi-Stakeholder Meeting on AIT for Children held at the Paul-Ehrlich-Institut in Langen, Germany, to provide a platform for discussion and exchange of thoughts to this topic between allergy experts from academia, regulators and AIT-manufacturers. The consented meeting minutes, conclusions and participants are presented.

Published
2020

8. Early-onset neonatal sepsis is associated with a high heart rate during automatically selected stationary periods

Author

Tu Pham, Laurent Vandenbroucke, Alain Beuchée, Alfredo Hernandez, Nga N'Guyen, Patrick Pladys, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Gynécologie et Obstétrique [Rennes] = Gynaecology [Rennes], CHU Pontchaillou [Rennes], Vietnam National University [Hanoï] (VNU), Département de Pédiatrie, Centre Hospitalier Universitaire [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de la Mère et de L'enfant, University of Hanoi, Vietnam, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Jonchère, Laurent

Subjects
Male, neonatal sepsis, Sepsis, 03 medical and health sciences, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Heart Rate, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, 030225 pediatrics, Heart rate, Humans, Medicine, Heart rate variability, Prospective Studies, 030212 general & internal medicine, [SPI.SIGNAL] Engineering Sciences [physics]/Signal and Image processing, Enterocolitis, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, Neonatal sepsis, Cardiac cycle, business.industry, Infant, Newborn, General Medicine, medicine.disease, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, 3. Good health, Pneumonia, newborn infant, Case-Control Studies, Anesthesia, Signal Processing, Pediatrics, Perinatology and Child Health, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Female, medicine.symptom, business, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing, Meningitis
Abstract

International audience; AIM: This study examined the heart rate variability characteristics associated with early-onset neonatal sepsis in a prospective, observational controlled study.METHODS: Eligible patients were full-term neonates hospitalised with clinical signs that suggested early-onset sepsis and a C-reactive protein of >10 mg/L. Sepsis was considered proven in cases of symptomatic septicaemia, meningitis, pneumonia or enterocolitis. Heart rate variability parameters (n = 16) were assessed from five-, 15- and 30-minute stationary sequences automatically selected from electrocardiographic recordings performed at admission and compared with a control group using the U-test with post hoc Benjamini-Yekutieli correction. Stationary sequences corresponded to the periods with the lowest changes of heart rate variability over time.RESULTS: A total of 40 full-term infants were enrolled, including 14 with proven sepsis. The mean duration of the cardiac cycle length was lower in the proven sepsis group than in the control group (n = 11), without other significant changes in heart rate variability parameters. These durations, measured in five-minute stationary periods, were 406 (367-433) ms in proven sepsis group versus 507 (463-522) ms in the control group (p < 0.05).CONCLUSION: Early-onset neonatal sepsis was associated with a high mean heart rate measured during automatically selected stationary periods.

Published
2017

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