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2. Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial

Author

Mitterer, Wolfgang, Binder, Christoph, Blassnig-Ezeh, Anya, Auer-Hackenberg, Lorenz, Berger, Angelika, Simma, Burkhard, Wald, Martin, Lee, Martin, and Kiechl-Kohlendorfer, Ursula

Subjects
Paediatrics, Biomedical and Clinical Sciences, Clinical Trials and Supportive Activities, Pediatric, Cardiovascular, Infant Mortality, Prevention, Nutrition, Clinical Research, Preterm, Low Birth Weight and Health of the Newborn, Pediatric Research Initiative, Perinatal Period - Conditions Originating in Perinatal Period, Heart Disease, Reproductive health and childbirth, Good Health and Well Being, Adult, Aging, Animals, Austria, Cattle, Diet, Female, Humans, Infant, Infant, Newborn, Infant, Premature, Milk, Human, Pregnancy, Premature Birth, Prospective Studies, Randomized Controlled Trials as Topic, Risk Factors, Neonatology, Prematurity, Preterm, Human milk, Human-milk-based fortifier, Cardiovascular risk, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine, Clinical sciences, Epidemiology, Health services and systems
Abstract

BackgroundPreterm birth accounts for approximately 11% of all livebirths globally. Due to improvements in perinatal care, more than 95% of these infants now survive into adulthood. Research has indicated a robust association between prematurity and increased cardiovascular risk factors and cardiovascular mortality. While the innate adverse effects of prematurity on these outcomes have been demonstrated, therapeutic strategies on the mitigation of these concerning developments are lacking. The primary objective of the NEOVASC clinical trial is therefore to investigate whether the administration of a prolonged exclusive human-milk diet in preterm infants is capable of alleviating the harmful effects of preterm birth on the early development of cardiovascular risk factors.MethodsThe NEOVASC study is a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial conducted in four Austrian tertiary neonatal care facilities. The purpose of the present trial is to investigate the effects of a prolonged exclusive human-milk-diet devoid of bovine-milk-based food components on cardiovascular and metabolic risk factors at 1, 2, and 5 years of corrected age. Primary outcomes include assessments of fasting blood glucose levels, blood pressure levels, and the distensibility of the descending aorta using validated echocardiographic protocols at 5 years of corrected age. The test group, which consists of 200 preterm infants, will therefore be compared to a control group of 100 term-born infants and a historical control group recruited previously.DiscussionGiven the emerging implications of an increased cardiovascular risk profile in the potentially growing population of preterm infants, further research on the mitigation of long-term morbidities in formerly preterm infants is urgently warranted. Further optimizing preterm infants' nutrition by removing bovine-milk-based food components may therefore be an interesting approach worth pursuing.Trial registrationClinicalTrials.gov NCT04413994 . Registered on 4 June 2020.

Published
2021

4. The newborn delivery room of tomorrow: emerging and future technologies

Author

Batey, Natalie, Henry, Caroline, Garg, Shalabh, Wagner, Michael, Malhotra, Atul, Valstar, Michel, Smith, Thomas, Sharkey, Don, Niemuth, Mara, Küster, Helmut, Rozycki, Henry, Solevåg, Anne Lee, Lara-Cantón, Inmaculada, Badurdeen, Shiraz, Dekker, Janneke, Davis, Peter, Roberts, Calum, te Pas, Arjan, Vento, Máximo, Simma, Burkhard, den Boer, Marieke, Herrick, Heidi Meredith, Rüdiger, Mario, Kaufmann, Maxi, Aichner, Heidi, Gupta, Samir, deBoode, Willem, Roehr, Charles Christoph, Nakstad, Britt, and Hooper, Stuart

Subjects
Pediatrics, Perinatology and Child Health
Abstract

Abstract Advances in neonatal care have resulted in improved outcomes for high-risk newborns with technologies playing a significant part although many were developed for the neonatal intensive care unit. The care provided in the delivery room (DR) during the first few minutes of life can impact short- and long-term neonatal outcomes. Increasingly, technologies have a critical role to play in the DR particularly with monitoring and information provision. However, the DR is a unique environment and has major challenges around the period of foetal to neonatal transition that need to be overcome when developing new technologies. This review focuses on current DR technologies as well as those just emerging and further over the horizon. We identify what key opinion leaders in DR care think of current technologies, what the important DR measures are to them, and which technologies might be useful in the future. We link these with key technologies including respiratory function monitors, electoral impedance tomography, videolaryngoscopy, augmented reality, video recording, eye tracking, artificial intelligence, and contactless monitoring. Encouraging funders and industry to address the unique technological challenges of newborn care in the DR will allow the continued improvement of outcomes of high-risk infants from the moment of birth. Impact Technological advances for newborn delivery room care require consideration of the unique environment, the variable patient characteristics, and disease states, as well as human factor challenges. Neonatology as a speciality has embraced technology, allowing its rapid progression and improved outcomes for infants, although innovation in the delivery room often lags behind that in the intensive care unit. Investing in new and emerging technologies can support healthcare providers when optimising care and could improve training, safety, and neonatal outcomes.

Published
2022

5. Additional file 1 of Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial

Author

Mitterer, Wolfgang, Binder, Christoph, Blassnig-Ezeh, Anya, Auer-Hackenberg, Lorenz, Berger, Angelika, Simma, Burkhard, Wald, Martin, Lee, Martin, and Kiechl-Kohlendorfer, Ursula

Abstract

Additional file 1: Figure S1. Trial flow chart.

Published
2021
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6. Additional file 2 of Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial

Author

Mitterer, Wolfgang, Binder, Christoph, Blassnig-Ezeh, Anya, Auer-Hackenberg, Lorenz, Berger, Angelika, Simma, Burkhard, Wald, Martin, Lee, Martin, and Kiechl-Kohlendorfer, Ursula

Abstract

Additional file 2. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Published
2021
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7. Identification of regulatory variants associated with genetic susceptibility to meningococcal disease

Author

Borghini, Lisa, Png, Eileen, Binder, Alexander, Wright, Victoria J, Pinnock, Ellie, de Groot, Ronald, Hazelzet, Jan, Emonts, Marieke, Van der Flier, Michiel, Schlapbach, Luregn J, Anderson, Suzanne, Secka, Fatou, Salas, Antonio, Fink, Colin, Carrol, Enitan D, Pollard, Andrew J, Coin, Lachlan J, Kuijpers, Taco W, Martinon-Torres, Federico, Zenz, Werner, Levin, Michael, Hibberd, Martin L, Davila, Sonia, Gormley, Stuart, Hamilton, Shea, Herberg, Jethro, Hourmat, Bernardo, Hoggart, Clive, Kaforou, Myrsini, Sancho-Shimizu, Vanessa, Abdulla, Amina, Agapow, Paul, Bartlett, Maeve, Bellos, Evangelos, Eleftherohorinou, Hariklia, Galassini, Rachel, Inwald, David, Mashbat, Meg, Menikou, Stefanie, Mustafa, Sobia, Nadel, Simon, Rahman, Rahmeen, Thakker, Clare, Bokhandi, S, Power, Sue, Barham, Heather, Pathan, N, Ridout, Jenna, White, Deborah, Thurston, Sarah, Faust, S, Patel, S, McCorkell, Jenni, Davies, P, Cratev, Lindsey, Navarra, Helen, Carter, Stephanie, Ramaiah, R, Patel, Rekha, Tuffrey, Catherine, Gribbin, Andrew, McCready, Sharon, Peters, Mark, Hardy, Katie, Standing, Fran, O'Neill, Lauren, Abelake, Eugenia, Deep, Akash, Nsirim, Eniola, Willis, Louise, Young, Zoe, Royad, C, White, Sonia, Fortune, PM, Hudnott, Phil, Alvez Gonzalez, Fernando, Barral-Arca, Ruth, Cebey-Lopez, Miriam, Jose Curras-Tuala, Maria, Garcia, Natalia, Garcia Vicente, Luisa, Gomez-Carballa, Alberto, Gomez Rial, Jose, Grela Beiroa, Andrea, Justicia Grande, Antonio, Leborans Iglesias, Pilar, Martinez Santos, Alba Elena, Martinon-Torres, Nazareth, Martinon Sanchez, Jose Maria, Mosquera Perez, Belen, Obando Pacheco, Pablo, Pardo-Seco, Jacobo, Pischedda, Sara, Rivero Calle, Irene, Rodriguez-Tenreiro, Carmen, Redondo-Collazo, Lorenzo, Seren Fernandez, Sonia, Porto Silva, Maria del Sol, Vega, Ana, Beatriz Reyes, Susana, Leon Leon, Maria Cruz, Navarro Mingorance, Alvaro, Gabaldo Barrios, Xavier, Onate Vergara, Eider, Concha Torre, Andres, Vivanco, Ana, Fernandez, Reyes, Gimenez Sanchez, Francisco, Sanchez Forte, Miguel, Rojo, Pablo, Ruiz Contreras, J, Palacios, Alba, Navarro, Marisa, Alvarez Alvarez, Cristina, Jose Lozano, Maria, Carreras, Eduardo, Brio Sanagustin, Sonia, Neth, Olaf, Martinez Padilla, Ma del Carmen, Prieto Tato, Luis Manuel, Guillen, Sara, Fernandez Silveira, Laura, Moreno, David, van Furth, AM Tutu, van der Flier, M, Boeddha, NP, Driessen, GJA, Pajkrt, D, Sanders, EAM, van de Beek, D, van der Ende, A, Philipsen, HLA, Adeel, AOA, Breukels, MA, Brinkman, DMC, de Korte, CCMM, de Vries, E, de Waal, WJ, Dekkers, R, Dings-Lammertink, A, Doedens, RA, Donker, AE, Dousma, M, Faber, TE, Gerrits, GPJM, Gerver, JAM, Heidema, J, Homan-van der Veen, J, Jacobs, MAM, Jansen, NJG, Kawczynski, P, Klucovska, K, Kneyber, MCJ, Koopman-Keemink, Y, Langenhorst, VJ, Leusink, J, Loza, BF, Merth, IT, Miedema, CJ, Neeleman, C, Noordzij, JG, Obihara, CC, van Overbeek-van Gils, ALT, Poortman, GH, Potgieter, ST, Potjewijd, J, Rosias, PPR, Sprong, T, ten Tussher, GW, Thio, BJ, Tramper-Stranders, GA, van Deuren, M, van der Meer, H, van Kuppevelt, AJM, van Wermeskerken, AM, Verwijs, WA, Wolfs, TFW, Agyeman, Philipp, Aebi, Christoph, Berger, Christoph, Giannoni, Eric, Stocker, Martin, Posfay-Barbe, Klara M, Heininger, Ulrich, Bernhard-Stirnemann, Sara, Niederer-Loher, Anita, Kahlert, Christian, Hasters, Paul, Relly, Christa, Baer, Walter, Paulus, Stephane, Frederick, Hannah, Jennings, Rebecca, Johnston, Joanne, Kenwright, Rhian, Agbeko, Rachel, Bojang, Kalifa, Sarr, Isatou, Kebbeh, Ngane, Sey, Gibbi, Saidykhan, Momodou, Cole, Fatoumatta, Thomas, Gilleh, Antonio, Martin, Walcher, Wolfgang, Geishofer, Gotho, Klobassa, Daniela, Martin, Mueller, Pfurtscheller, Klaus, Reiter, Karl, Roedl, Siegfried, Zobel, Gerfried, Zoehrer, Bettina, Toepke, Baerbel, Fucik, Peter, Gabriel, Markwart, Penzien, Johann M, Diab, Gedeon, Miething, Robert, Deeg, KH, Hammer, Jurg, Varnholt, Verena, Schmidt, Andreas, Bindl, Lutz, Sillaber, Ursula, Huemer, Christian, Meier, Primrose, Simic-Schleicher, G, Markart, Markus, Pfau, Eberhard, Broede, Hans, Ausserer, Bernd, Kalhoff, Hermann, Arpe, Volker, Schweitzer-Krantz, Susanne, Kasper, Johannes-Martin, Loranth, Kathrin, Bittrich, Hans J, Simma, Burkhard, Klinge, Jens, Fedlmaier, Michael, Weigand, Nicola, Herting, Egbert, Grube, Regina, Fusch, Christoph, Gruber, Alois, Schimmel, Ulf, Knaufer-Schiefer, Suzanne, Laessig, Wolfgang, Hennenberger, Axel, von der Wense, Axel, Tillmann, Roland, Schwarick, Juergen, Sitzmann, Friedrich C, Streif, Werner, Mueller, Herbert, Kurnik, Peter, Groneck, Peter, Weiss, Ute, Groeblacher-Roth, Helene, Bensch, Juergen, Moser, Reinhard, Schwarz, Rudolf, Lenz, Kurt, Hofmann, Thomas, Goepel, Wolfgang, Schulz, Dietrich, Berger, Thomas, Hauser, Erwin, Foerster, Kai Martin, Peters, Jochen, Nicolai, T Homas, Kumlien, Bjoern, Beckmann, Regina, Seitz, Christiane, Hueseman, D, Schuermann, Roland, Ta, Van Hop, Weikmann, Eckart, Evert, W, Hautz, Juergen, Seidenberg, Juergen, Wocko, Lucia, Luigs, Petra, Reiter, Hans-Ludwig, Quietzach, J, Koenig, Michael, Herrmann, Johanna, Mitter, Horst, Seidler, Ekkehard, Maak, Bernhard, Sperl, Wolfgang, Zwiauer, Karl, Meissl, Manfred, Koch, Reinhard, Cremer, Manfred, Breuer, HA, Goerke, W, Nossal, Robert, Pernice, Walter, Brangenberg, Ralf, Salzer, Hans R, Koch, Hartmut, Schaller, Gerhard, Paky, Franz, Strasser, Friedrich, Eitelberger, Franz, Sontheimer, D, Lischka, Andreas, Kronberger, Martina, Dilch, Alfred, Scheibenpflug, Christian, Bruckner, Robert, Mahler, Klaus, Runge, Klaus, Kunze, Wolfgang, Schermann, Peter, Consortium, EUCLIDS, European Commission, Meningitis Research Foundation, National Institute for Health Research (UK), Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne Hospitals NHS Foundation Trust, Instituto de Salud Carlos III, Xunta de Galicia, Wyeth Farma, Fundación Instituto de Investigación Sanitaria de Santiago de Compostela, Novartis, Swiss National Science Foundation, Swiss Society of Intensive Care Medicine, Gottfried und Julia Bangerter-Rhyner-Stiftung, Vinetum and Borer Foundation, Foundation for the Health of Children and Adolescents, Austrian National Bank, University of Zurich, Borghini, Lisa, Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría, Png, Eileen [0000-0001-5586-6395], Wright, Victoria J [0000-0001-7826-1516], Schlapbach, Luregn J [0000-0003-2281-2598], Salas, Antonio [0000-0002-2336-702X], Martinon-Torres, Federico [0000-0002-9023-581X], Apollo - University of Cambridge Repository, ARD - Amsterdam Reproduction and Development, AII - Infectious diseases, Paediatric Infectious Diseases / Rheumatology / Immunology, Neurology, ANS - Neuroinfection & -inflammation, Medical Microbiology and Infection Prevention, Pediatrics, Public Health, Posfay Barbe, Klara, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), APH - Aging & Later Life, Amsterdam Reproduction & Development (AR&D), and Pediatric surgery

Subjects
0301 basic medicine, Candidate gene, Hypopharyngeal Neoplasms / microbiology, Meningococcal Infections / microbiology, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], MathematicsofComputing_GENERAL, lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], lcsh:Medicine, Neisseria meningitidis, Regulatory Sequences, Nucleic Acid, Cohort Studies, 0302 clinical medicine, ComputingMethodologies_SYMBOLICANDALGEBRAICMANIPULATION, Hypopharyngeal Neoplasms / pathology, BINDING, Tumor Cells, Cultured, lcsh:Science, Genetics, Multidisciplinary, ddc:618, Cultured, TheoryofComputation_GENERAL, High-Throughput Nucleotide Sequencing, Genomics, Phenotype, 3. Good health, ddc, Tumor Cells, Multidisciplinary Sciences, GENOME, Science & Technology - Other Topics, Neisseria meningitidis / isolation & purification, Single-nucleotide polymorphism, 610 Medicine & health, KAPPA-B, Biology, Hypopharyngeal Neoplasms / genetics, Polymorphism, Single Nucleotide, Article, Meningococcal Infections / epidemiology, 03 medical and health sciences, SEQUENCE VARIATION, Genetic predisposition, Journal Article, Humans, Meningitis, Meningococcal Infections / genetics, Genetic Predisposition to Disease, Nucleic Acid, Polymorphism, General, Gene, Genotyping, Neisseria meningitidis / genetics, Genetic Association Studies, Genetic association, Genetic association study, 1000 Multidisciplinary, Science & Technology, Hypopharyngeal Neoplasms, genetic variants, meningococcal disease, lcsh:R, Single Nucleotide, EUCLIDS consortium, Gene regulation, Meningococcal Infections, 030104 developmental biology, 10036 Medical Clinic, Case-Control Studies, lcsh:Q, Software_PROGRAMMINGLANGUAGES, Regulatory Sequences, 030217 neurology & neurosurgery
Abstract

EUCLIDS consortium., Non-coding genetic variants play an important role in driving susceptibility to complex diseases but their characterization remains challenging. Here, we employed a novel approach to interrogate the genetic risk of such polymorphisms in a more systematic way by targeting specific regulatory regions relevant for the phenotype studied. We applied this method to meningococcal disease susceptibility, using the DNA binding pattern of RELA – a NF-kB subunit, master regulator of the response to infection – under bacterial stimuli in nasopharyngeal epithelial cells. We designed a custom panel to cover these RELA binding sites and used it for targeted sequencing in cases and controls. Variant calling and association analysis were performed followed by validation of candidate polymorphisms by genotyping in three independent cohorts. We identified two new polymorphisms, rs4823231 and rs11913168, showing signs of association with meningococcal disease susceptibility. In addition, using our genomic data as well as publicly available resources, we found evidences for these SNPs to have potential regulatory effects on ATXN10 and LIF genes respectively. The variants and related candidate genes are relevant for infectious diseases and may have important contribution for meningococcal disease pathology. Finally, we described a novel genetic association approach that could be applied to other phenotypes., This work has been partially funded by the European Seventh Framework Programme for Research and Technological Development (FP7) under EUCLIDS Grant Agreement No. 279185. The UK meningococcal cohort was established with support from Meningitis Research Foundation through grants to Imperial College London. The Research from Newcastle partners was supported by the National Institute for Health Research Newcastle Biomedical Research Centre based at Newcastle Hospitals NHS Foundation Trust and Newcastle University. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The ESIGEM Research group activities were supported by grants from Instituto de Salud Carlos III (Proyecto de Investigación en Salud, Acción Estratégica en Salud: proyecto GePEM PI16/01478) (A.S.); Consellería de Sanidade, Xunta de Galicia (RHI07/2-intensificación actividad investigadora, PS09749 and 10PXIB918184PR), Instituto de Salud Carlos III (Intensificación de la actividad investigadora 2007–2016), Convenio de colaboración de investigación (Wyeth España-Fundación IDICHUS 2007–2011), Convenio de colaboración de investigación (Novartis España-Fundación IDICHUS 2010–2011), Fondo de Investigación Sanitaria (FIS; PI070069/PI1000540) del plan nacional de I + D + I and ‘fondos FEDER’ (F.M.T.). The Swiss Pediatric Sepsis study was funded by grants from the Swiss National Science Foundation (342730_153158/1), the Swiss Society of Intensive Care, the Bangerter Foundation, the Vinetum and Borer Foundation, and the Foundation for the Health of Children and Adolescents. The Western Europe Meningococcal Study was supported by grants no 8842, 10112 and 12710 of the Oesterreichische Nationalbank (Austria), grants A3-16.K-8/2008-11 and A3-16.K-8/2006–9 of the Department for Science and Research of the Styrian federal government (Austria) and the non for profit association ‘In Vita’, Graz (Austria).

Published
2019

10. Nocturnal asthma is affected by genetic interactions between RORA and NPSR1

Author

Gaertner, Vincent D., Michel, Sven, Curtin, John A., Pulkkinen, Ville, Acevedo, Nathalie, Soderhall, Cilla, von Berg, Andrea, Bufe, Albrecht, Laub, Otto, Rietschel, Ernst, Heinzmann, Andrea, Simma, Burkhard, Vogelberg, Christian, Pershagen, Goeran, Melen, Erik, Simpson, Angela, Custovic, Adnan, Kere, Juha, Kabesch, Michael, Gaertner, Vincent D., Michel, Sven, Curtin, John A., Pulkkinen, Ville, Acevedo, Nathalie, Soderhall, Cilla, von Berg, Andrea, Bufe, Albrecht, Laub, Otto, Rietschel, Ernst, Heinzmann, Andrea, Simma, Burkhard, Vogelberg, Christian, Pershagen, Goeran, Melen, Erik, Simpson, Angela, Custovic, Adnan, Kere, Juha, and Kabesch, Michael

Abstract

BackgroundNeuropeptide S Receptor 1 (NPSR1) and Retinoid Acid Receptor-Related Orphan Receptor Alpha (RORA ) interact biologically, are both known candidate genes for asthma, and are involved in controlling circadian rhythm. Thus, we assessed (1) whether interactions between RORA and NPSR1 specifically affect the nocturnal asthma phenotype and (2) how this may differ from other asthma phenotypes. MethodsInteraction effects between 24 single-nucleotide polymorphisms (SNPs) in RORA and 35 SNPs in NPSR1 on asthma and nocturnal asthma symptoms were determined in 1432 subjects (763 asthmatics [192 with nocturnal asthma symptoms]; 669 controls) from the Multicenter Asthma Genetic in Childhood/International Study of Asthma and Allergies in Childhood studies. The results were validated and extended in children from the Manchester Asthma and Allergy Study (N=723) and the Children Allergy Milieu Stockholm and Epidemiological cohort (N=1646). ResultsRORA*NPSR1 interactions seemed to affect both asthma and nocturnal asthma. In stratified analyses, however, interactions mainly affected nocturnal asthma and less so asthma without nocturnal symptoms or asthma severity. Results were replicated in two independent cohorts and seemed to remain constant over time throughout youth. ConclusionRORA*NPSR1 interactions appear to be involved in mechanisms specific for nocturnal asthma. In contrast to previous studies focusing on the role of beta 2 receptor polymorphisms in nocturnal asthma as a feature of asthma control or severity in general, our data suggest that changes in circadian rhythm control are associated with nighttime asthma symptoms.

Published
2019

11. Neonatal assessment in the delivery room - Trial to Evaluate a Specified Type of Apgar (TEST-Apgar)

Author

Rüdiger, Mario, Braun, Nicole, Aranda, Jacob, Aguar, Marta, Bergert, Renate, Bystricka, Alica, Dimitriou, Gabriel, El-Atawi, Khaled, Ifflaender, Sascha, Jung, Philipp, Matasova, Katarina, Ojinaga, Violeta, Petruskeviciene, Zita, Roll, Claudia, Schwindt, Jens, Simma, Burkhard, Staal, Nanette, Valencia, Gloria, Vasconcellos, Maria Gabriela, Veinla, Maie, Vento, Máximo, Weber, Benedikt, Wendt, Anke, Yigit, Sule, Zotter, Heinz, Küster, Helmut, and TEST-Apgar study-group

Subjects
Delivery room management, Postnatal condition, Expanded-Apgar, Specified-Apgar, Apgar score, Neonatal assessment, Preterm resuscitation
Abstract

Background: Since an objective description is essential to determine infant's postnatal condition and efficacy of interventions, two scores were suggested in the past but weren't tested yet: The Specified-Apgar uses the 5 items of the conventional Apgar score; however describes the condition regardless of gestational age (GA) or resuscitative interventions. The Expanded-Apgar measures interventions needed to achieve this condition. We hypothesized that the combination of both (Combined-Apgar) describes postnatal condition of preterm infants better than either of the scores alone. Methods: Scores were assessed in preterm infants below 32 completed weeks of gestation. Data were prospectively collected in 20 NICU in 12 countries. Prediction of poor outcome ( death, severe/moderate BPD, IVH, CPL and ROP) was used as a surrogate parameter to compare the scores. To compare predictive value the AUC for the ROC was calculated. Results: Of 2150 eligible newborns, data on 1855 infants with a mean GA of 28(6/7) +/- 2(3/7) weeks were analyzed. At 1 minute, the Combined-Apgar was significantly better in predicting poor outcome than the Specified- or Expanded-Apgar alone. Of infants with a very low score at 5 or 10 minutes 81% or 100% had a poor outcome, respectively. In these infants the relative risk (RR) for perinatal mortality was 24.93 (13.16-47.20) and 31.34 (15.91-61.71), respectively. Conclusion: The Combined-Apgar allows a more appropriate description of infant's condition under conditions of modern neonatal care. It should be used as a tool for better comparison of group of infants and postnatal interventions.

Published
2015

12. Doublesex and mab-3 related transcription factor 1 (DMRT1) is a sex-specific genetic determinant of childhood-onset asthma and is expressed in testis and macrophages

Author

Schieck, Maximilian, Schouten, Jan P, Michel, Sven, Suttner, Kathrin, Toncheva, Antoaneta A, Gaertner, Vincent D, Illig, Thomas, Lipinski, Simone, Franke, Andre, Klintschar, Michael, Kalayci, Omer, Sahiner, Umit M, Birben, Esra, Melén, Erik, Pershagen, Göran, Freidin, Maxim B, Ogorodova, Ludmila M, Granell, Raquel, Henderson, John, Brunekreef, Bert, Smit, Henriëtte A, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Genuneit, Jon, Jonigk, Danny, Postma, Dirkje S, Koppelman, Gerard H, Vonk, Judith M, Timens, Wim, Boezen, H Marike, Kabesch, Michael, Schieck, Maximilian, Schouten, Jan P, Michel, Sven, Suttner, Kathrin, Toncheva, Antoaneta A, Gaertner, Vincent D, Illig, Thomas, Lipinski, Simone, Franke, Andre, Klintschar, Michael, Kalayci, Omer, Sahiner, Umit M, Birben, Esra, Melén, Erik, Pershagen, Göran, Freidin, Maxim B, Ogorodova, Ludmila M, Granell, Raquel, Henderson, John, Brunekreef, Bert, Smit, Henriëtte A, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Genuneit, Jon, Jonigk, Danny, Postma, Dirkje S, Koppelman, Gerard H, Vonk, Judith M, Timens, Wim, Boezen, H Marike, and Kabesch, Michael

Published
2016

13. Doublesex and mab-3 related transcription factor 1 (DMRT1) is a sex-specific genetic determinant of childhood-onset asthma and is expressed in testis and macrophages

Author

dIRAS RA-2, Schieck, Maximilian, Schouten, Jan P, Michel, Sven, Suttner, Kathrin, Toncheva, Antoaneta A, Gaertner, Vincent D, Illig, Thomas, Lipinski, Simone, Franke, Andre, Klintschar, Michael, Kalayci, Omer, Sahiner, Umit M, Birben, Esra, Melén, Erik, Pershagen, Göran, Freidin, Maxim B, Ogorodova, Ludmila M, Granell, Raquel, Henderson, John, Brunekreef, Bert, Smit, Henriëtte A, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Genuneit, Jon, Jonigk, Danny, Postma, Dirkje S, Koppelman, Gerard H, Vonk, Judith M, Timens, Wim, Boezen, H Marike, Kabesch, Michael, dIRAS RA-2, Schieck, Maximilian, Schouten, Jan P, Michel, Sven, Suttner, Kathrin, Toncheva, Antoaneta A, Gaertner, Vincent D, Illig, Thomas, Lipinski, Simone, Franke, Andre, Klintschar, Michael, Kalayci, Omer, Sahiner, Umit M, Birben, Esra, Melén, Erik, Pershagen, Göran, Freidin, Maxim B, Ogorodova, Ludmila M, Granell, Raquel, Henderson, John, Brunekreef, Bert, Smit, Henriëtte A, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Genuneit, Jon, Jonigk, Danny, Postma, Dirkje S, Koppelman, Gerard H, Vonk, Judith M, Timens, Wim, Boezen, H Marike, and Kabesch, Michael

Published
2016

14. Doublesex and mab-3 related transcription factor 1 (DMRT1) is a sex-specific genetic determinant of childhood-onset asthma and is expressed in testis and macrophages

Author

Epi Infectieziekten Team 3, Infection & Immunity, Circulatory Health, JC onderzoeksprogramma Infectieziekten, Cardiometabolic Health, Child Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Schieck, Maximilian, Schouten, Jan P, Michel, Sven, Suttner, Kathrin, Toncheva, Antoaneta A, Gaertner, Vincent D, Illig, Thomas, Lipinski, Simone, Franke, Andre, Klintschar, Michael, Kalayci, Omer, Sahiner, Umit M, Birben, Esra, Melén, Erik, Pershagen, Göran, Freidin, Maxim B, Ogorodova, Ludmila M, Granell, Raquel, Henderson, John, Brunekreef, Bert, Smit, Henriëtte A, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Genuneit, Jon, Jonigk, Danny, Postma, Dirkje S, Koppelman, Gerard H, Vonk, Judith M, Timens, Wim, Boezen, H Marike, Kabesch, Michael, Epi Infectieziekten Team 3, Infection & Immunity, Circulatory Health, JC onderzoeksprogramma Infectieziekten, Cardiometabolic Health, Child Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Schieck, Maximilian, Schouten, Jan P, Michel, Sven, Suttner, Kathrin, Toncheva, Antoaneta A, Gaertner, Vincent D, Illig, Thomas, Lipinski, Simone, Franke, Andre, Klintschar, Michael, Kalayci, Omer, Sahiner, Umit M, Birben, Esra, Melén, Erik, Pershagen, Göran, Freidin, Maxim B, Ogorodova, Ludmila M, Granell, Raquel, Henderson, John, Brunekreef, Bert, Smit, Henriëtte A, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Genuneit, Jon, Jonigk, Danny, Postma, Dirkje S, Koppelman, Gerard H, Vonk, Judith M, Timens, Wim, Boezen, H Marike, and Kabesch, Michael

Published
2016

15. Neonatal assessment in the delivery room – Trial to Evaluate a Specified Type of Apgar (TEST-Apgar)

Author

TEST-Apgar study-group, Rüdiger, Mario, Braun, Nicole, Aranda, Jacob, Aguar, Marta, Bergert, Renate, Bystricka, Alica, Dimitriou, Gabriel, El-Atawi, Khaled, Ifflaender, Sascha, Jung, Philipp, Matasova, Katarina, Ojinaga, Violeta, Petruskeviciene, Zita, Roll, Claudia, Schwindt, Jens, Simma, Burkhard, Staal, Nanette, Valencia, Gloria, Vasconcellos, Maria Gabriela, Veinla, Maie, Vento, Máximo, Weber, Benedikt, Wendt, Anke, Yigit, Sule, Zotter, Heinz, Küster, Helmut, TEST-Apgar study-group, Rüdiger, Mario, Braun, Nicole, Aranda, Jacob, Aguar, Marta, Bergert, Renate, Bystricka, Alica, Dimitriou, Gabriel, El-Atawi, Khaled, Ifflaender, Sascha, Jung, Philipp, Matasova, Katarina, Ojinaga, Violeta, Petruskeviciene, Zita, Roll, Claudia, Schwindt, Jens, Simma, Burkhard, Staal, Nanette, Valencia, Gloria, Vasconcellos, Maria Gabriela, Veinla, Maie, Vento, Máximo, Weber, Benedikt, Wendt, Anke, Yigit, Sule, Zotter, Heinz, and Küster, Helmut

Abstract

Background: Since an objective description is essential to determine infant’s postnatal condition and efficacy of interventions, two scores were suggested in the past but weren’t tested yet: The Specified-Apgar uses the 5 items of the conventional Apgar score; however describes the condition regardless of gestational age (GA) or resuscitative interventions. The Expanded-Apgar measures interventions needed to achieve this condition. We hypothesized that the combination of both (Combined-Apgar) describes postnatal condition of preterm infants better than either of the scores alone. Methods: Scores were assessed in preterm infants below 32 completed weeks of gestation. Data were prospectively collected in 20 NICU in 12 countries. Prediction of poor outcome (death, severe/moderate BPD, IVH, CPL and ROP) was used as a surrogate parameter to compare the scores. To compare predictive value the AUC for the ROC was calculated. Results: Of 2150 eligible newborns, data on 1855 infants with a mean GA of 286/7± 23/7 weeks were analyzed. At 1 minute, the Combined-Apgar was significantly better in predicting poor outcome than the Specified- or Expanded-Apgar alone. Of infants with a very low score at 5 or 10 minutes 81% or 100% had a poor outcome, respectively. In these infants the relative risk (RR) for perinatal mortality was 24.93 (13.16-47.20) and 31.34 (15.91-61.71), respectively. Conclusion: The Combined-Apgar allows a more appropriate description of infant’s condition under conditions of modern neonatal care. It should be used as a tool for better comparison of group of infants and postnatal interventions.

Published
2015

18. Genetic variation in T(H)17 pathway genes, childhood asthma, and total serum IgE levels

Author

Schieck, Maximilian, Michel, Sven, Suttner, Kathrin, Illig, Thomas, Zeilinger, Sonja, Franke, Andre, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Frischer, Thomas, Genuneit, Jon, Kerzel, Sebastian, Kabesch, Michael, Schieck, Maximilian, Michel, Sven, Suttner, Kathrin, Illig, Thomas, Zeilinger, Sonja, Franke, Andre, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Frischer, Thomas, Genuneit, Jon, Kerzel, Sebastian, and Kabesch, Michael

Published
2014

19. Genetic variants in Protocadherin-1, bronchial hyper-responsiveness, and asthma subphenotypes in German children

Author

Toncheva, Antoaneta A., Suttner, Kathrin, Michel, Sven, Klopp, Norman, Illig, Thomas, Balschun, Tobias, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Frischer, Thomas, Genuneit, Jon, von Mutius, Erika, Kabesch, Michael, Toncheva, Antoaneta A., Suttner, Kathrin, Michel, Sven, Klopp, Norman, Illig, Thomas, Balschun, Tobias, Vogelberg, Christian, von Berg, Andrea, Bufe, Albrecht, Heinzmann, Andrea, Laub, Otto, Rietschel, Ernst, Simma, Burkhard, Frischer, Thomas, Genuneit, Jon, von Mutius, Erika, and Kabesch, Michael

Abstract

Background: Recently, Protocadherin-1 (PCDH1) was reported as a novel susceptibility gene for bronchial hyper-responsiveness (BHR) and asthma. PCDH1 is located on chromosome 5q31-33, in the vicinity of several known candidate genes for asthma and allergy. To exclude that the associations observed for PCDH1 originate from the nearby cytokine cluster, an extensive linkage disequilibrium (LD) analysis was performed. Effects of polymorphisms in PCDH1 on asthma, BHR, and related phenotypes were studied comprehensively. Methods: Genotype information was acquired from Illumina HumanHap300Chip genotyping, MALDI-TOF MS genotyping, and imputation. LD was assessed by Haploview 4.2 software. Associations were investigated in a population of 1454 individuals (763 asthmatics) from two German study populations [MAGICS and International Study of Asthma and Allergies in Childhood phase II (ISAAC II)] using logistic regression to model additive effects. Results: No relevant LD between PCDH1 tagging polymorphisms and 98 single nucleotide polymorphisms within the cytokine cluster was detected. While BHR was not associated with PCDH1 polymorphisms, significant associations with subphenotypes of asthma were observed. Conclusion: Protocadherin-1 polymorphisms may specifically affect the development of non-atopic asthma in children. Functional studies are needed to further investigate the role of PCDH1 in BHR and asthma development.

Published
2012

20. Unifying Candidate Gene and GWAS Approaches in Asthma

Author

Michel, Sven, Liang, Liming, Depner, Martin, Klopp, Norman, Ruether, Andreas, Kumar, Ashish, Schedel, Michaela, Vogelberg, Christian, von Mutius, Erika, von Berg, Andrea, Bufe, Albrecht, Rietschel, Ernst, Heinzmann, Andrea, Laub, Otto, Simma, Burkhard, Frischer, Thomas, Genuneit, Jon, Gut, Ivo G., Schreiber, Stefan, Lathrop, Mark, Illig, Thomas, Kabesch, Michael, Michel, Sven, Liang, Liming, Depner, Martin, Klopp, Norman, Ruether, Andreas, Kumar, Ashish, Schedel, Michaela, Vogelberg, Christian, von Mutius, Erika, von Berg, Andrea, Bufe, Albrecht, Rietschel, Ernst, Heinzmann, Andrea, Laub, Otto, Simma, Burkhard, Frischer, Thomas, Genuneit, Jon, Gut, Ivo G., Schreiber, Stefan, Lathrop, Mark, Illig, Thomas, and Kabesch, Michael

Abstract

The first genome wide association study (GWAS) for childhood asthma identified a novel major susceptibility locus on chromosome 17q21 harboring the ORMDL3 gene, but the role of previous asthma candidate genes was not specifically analyzed in this GWAS. We systematically identified 89 SNPs in 14 candidate genes previously associated with asthma in >3 independent study populations. We re-genotyped 39 SNPs in these genes not covered by GWAS performed in 703 asthmatics and 658 reference children. Genotyping data were compared to imputation data derived from Illumina HumanHap300 chip genotyping. Results were combined to analyze 566 SNPs covering all 14 candidate gene loci. Genotyped polymorphisms in ADAM33, GSTP1 and VDR showed effects with p-values <0.0035 (corrected for multiple testing). Combining genotyping and imputation, polymorphisms in DPP10, EDN1, IL12B, IL13, IL4, IL4R and TNF showed associations at a significance level between p = 0.05 and p = 0.0035. These data indicate that (a) GWAS coverage is insufficient for many asthma candidate genes, (b) imputation based on these data is reliable but incomplete, and (c) SNPs in three previously identified asthma candidate genes replicate in our GWAS population with significance after correction for multiple testing in 14 genes.

Published
2010

21. Unifying Candidate Gene and GWAS Approaches in Asthma

Author

Michel, Sven, primary, Liang, Liming, additional, Depner, Martin, additional, Klopp, Norman, additional, Ruether, Andreas, additional, Kumar, Ashish, additional, Schedel, Michaela, additional, Vogelberg, Christian, additional, von Mutius, Erika, additional, von Berg, Andrea, additional, Bufe, Albrecht, additional, Rietschel, Ernst, additional, Heinzmann, Andrea, additional, Laub, Otto, additional, Simma, Burkhard, additional, Frischer, Thomas, additional, Genuneit, Jon, additional, Gut, Ivo G., additional, Schreiber, Stefan, additional, Lathrop, Mark, additional, Illig, Thomas, additional, and Kabesch, Michael, additional

Published
2010
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25. A critical appraisal of tools for delivery room assessment of the newborn infant.

Author

Niemuth M, Küster H, Simma B, Rozycki H, Rüdiger M, and Solevåg AL

Abstract

Assessment of an infant's condition in the delivery room represents a prerequisite to adequately initiate medical support. In her seminal paper, Virginia Apgar described five parameters to be used for such an assessment. However, since that time maternal and neonatal care has changed; interventions were improved and infants are even more premature. Nevertheless, the Apgar score is assigned to infants worldwide but there are concerns about low interobserver reliability, especially in preterm infants. Also, resuscitative interventions may preclude the interpretation of the score, which is of concern when used as an outcome parameter in delivery room intervention studies. Within the context of these changes, we performed a critical appraisal on how to assess postnatal condition of the newborn including the clinical parameters of the Apgar score, as well as selected additional parameters and a proposed new scoring system. The development of a new scoring system that guide clinicians in assessing infants and help to decide how to support postnatal adaptation is discussed. IMPACT: This critical paper discusses the reliability of the Apgar score, as well as additional parameters, in order to improve assessment of a newborn's postnatal condition. A revised neonatal scoring system should account for infant maturity and the interventions administered. Delivery room assessment should be directed toward determining how much medical support is needed and how the infant responds to these interventions., (© 2021. The Author(s), under exclusive licence to the International Pediatric Research Foundation, Inc.)

Published
2021
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26. Neonatal assessment in the delivery room--Trial to Evaluate a Specified Type of Apgar (TEST-Apgar).

Author

Rüdiger M, Braun N, Aranda J, Aguar M, Bergert R, Bystricka A, Dimitriou G, El-Atawi K, Ifflaender S, Jung P, Matasova K, Ojinaga V, Petruskeviciene Z, Roll C, Schwindt J, Simma B, Staal N, Valencia G, Vasconcellos MG, Veinla M, Vento M, Weber B, Wendt A, Yigit S, Zotter H, and Küster H

Subjects
Delivery Rooms, Female, Gestational Age, Humans, Infant, Infant Mortality, Infant, Newborn, Pregnancy, Prognosis, Risk Factors, Apgar Score, Infant, Premature
Abstract

Background: Since an objective description is essential to determine infant's postnatal condition and efficacy of interventions, two scores were suggested in the past but weren't tested yet: The Specified-Apgar uses the 5 items of the conventional Apgar score; however describes the condition regardless of gestational age (GA) or resuscitative interventions. The Expanded-Apgar measures interventions needed to achieve this condition. We hypothesized that the combination of both (Combined-Apgar) describes postnatal condition of preterm infants better than either of the scores alone., Methods: Scores were assessed in preterm infants below 32 completed weeks of gestation. Data were prospectively collected in 20 NICU in 12 countries. Prediction of poor outcome (death, severe/moderate BPD, IVH, CPL and ROP) was used as a surrogate parameter to compare the scores. To compare predictive value the AUC for the ROC was calculated., Results: Of 2150 eligible newborns, data on 1855 infants with a mean GA of 28(6/7) ± 2(3/7) weeks were analyzed. At 1 minute, the Combined-Apgar was significantly better in predicting poor outcome than the Specified- or Expanded-Apgar alone. Of infants with a very low score at 5 or 10 minutes 81% or 100% had a poor outcome, respectively. In these infants the relative risk (RR) for perinatal mortality was 24.93 (13.16-47.20) and 31.34 (15.91-61.71), respectively., Conclusion: The Combined-Apgar allows a more appropriate description of infant's condition under conditions of modern neonatal care. It should be used as a tool for better comparison of group of infants and postnatal interventions., Trial Registration: clinicaltrials.gov Protocol Registration System (NCT00623038). Registered 14 February 2008.

Published
2015
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