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Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants.
Hansen, Mathias Lühr; Pellicer, Adelina; Gluud, Christian; Dempsey, Eugene; Mintzer, Jonathan; Hyttel-Sorensen, Simon; Heuchan, Anne Marie; Hagmann, Cornelia; Dimitriou, Gabriel; Pichler, Gerhard; Naulaers, Gunnar; Cheng, Guoqiang; Vilan, Ana; Tkaczyk, Jakub; Kreutzer, Karen B; Fumagalli, Monica; Claris, Olivier; Fredly, Siv; Szczapa, Tomasz; Lange, Theis; Jakobsen, Janus Christian; Greisen, Gorm.
Afiliación
  • Hansen ML; Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. mathias.safeboosc@gmail.com.
  • Pellicer A; Department of Neonatology, La Paz University Hospital, Paseo De La Castellana 261, 28046, Madrid, Spain.
  • Gluud C; Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
  • Dempsey E; Infant Centre and Department of Paediatrics and Child Health, University College Cork, College Road, Cork, Ireland.
  • Mintzer J; Division of Neonatal-Perinatal Medicine, Mountainside Medical Center, Montclair, NJ, USA.
  • Hyttel-Sorensen S; Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
  • Heuchan AM; Department of Neonatology, Royal Hospital for Children, 1345 Govan Rd, Glasgow, G51 4TF, UK.
  • Hagmann C; Department of Neonatology, Children's University Hospital of Zürich, Steinweisstrasse 75, 8037, Zurich, Switzerland.
  • Dimitriou G; NICU, Department of Pediatrics, University General Hospital of Patras, 265 04, Patras, Greece.
  • Pichler G; Department of Pediatrics, Medical University of Graz, Auenbruggerplatz 30, Graz, Austria.
  • Naulaers G; Department of Neonatology, University Hospital Leuven, Herestraat 49, Leuven, Belgium.
  • Cheng G; Department of Neonatology, Children's Hospital of Fudan University, 399 Wanyuan Rd, Minhang Qu, Shanghai Shi, China.
  • Vilan A; Department of Neonatology, Centrohospitalar Universitário de São João, Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal.
  • Tkaczyk J; Department of Neonatology, University Hospital Motol, V Uvalu 84, 150 06, Prague 5, Czech Republic.
  • Kreutzer KB; Department of Neonatology, University Children's Hospital Tuebingen, Hoppe-Seyler-Straße 1, 72076, Tuebingen, Germany.
  • Fumagalli M; Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, Via della Commenda 12, 20122, Milan, Italy.
  • Claris O; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
  • Fredly S; Department of Neonatology, Hospices Civil De Lyon, 3 Quai des Célestins, 69002, Lyon, France.
  • Szczapa T; Department of Neonatology, Oslo University Hospital, Kirkeveien, 166 0450, Oslo, Norway.
  • Lange T; Department of Neonatology, Poznan University of Medical Sciences, Polna 33, 60-535, Poznan, Poland.
  • Jakobsen JC; Section of Biostatistics, Department of Publich Health, Copenhagen University, Øster Farimagsgade 5, Copenhagen K, Denmark.
  • Greisen G; Center for Statistical Science, Peking University, Beijing, China.
Trials ; 20(1): 746, 2019 Dec 19.
Article en En | MEDLINE | ID: mdl-31856902
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Oxígeno / Encéfalo / Hipoxia Encefálica / Tratamiento de Urgencia / Recien Nacido Extremadamente Prematuro / Monitoreo Fisiológico Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Prognostic_studies / Qualitative_research Límite: Humans / Newborn Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2019 Tipo del documento: Article País de afiliación: Dinamarca
Texto completo
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Oxígeno / Encéfalo / Hipoxia Encefálica / Tratamiento de Urgencia / Recien Nacido Extremadamente Prematuro / Monitoreo Fisiológico Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Prognostic_studies / Qualitative_research Límite: Humans / Newborn Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2019 Tipo del documento: Article País de afiliación: Dinamarca