دورية أكاديمية
Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol
| العنوان: | Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol |
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| المؤلفون: | Mylrea-Foley, Bronacha, Thornton, Jim G, Mullins, Edward, Marlow, Neil, Hecher, Kurt, Ammari, Christina, Arabin, Birgit, Berger, Astrid, Bergman, Eva, Bhide, Amarnath, Bilardo, Caterina, Binder, Julia, Breeze, Andrew, Brodszki, Jana, Calda, Pavel, Cannings-John, Rebecca, Černý, Andrej, Cesari, Elena, Cetin, Irene, Dall'Asta, Andrea, Diemert, Anke, Ebbing, Cathrine, Eggebø, Torbjørn, Fantasia, Ilaria, Ferrazzi, Enrico, Frusca, Tiziana, Ghi, Tullio, Goodier, Jenny, Greimel, Patrick, Gyselaers, Wilfried, Hassan, Wassim, Von Kaisenberg, Constantin, Kholin, Alexey, Klaritsch, Philipp, Krofta, Ladislav, Lindgren, Peter, Lobmaier, Silvia, Marsal, Karel, Maruotti, Giuseppe M, Mecacci, Federico, Myklestad, Kirsti, Napolitano, Raffaele, Ostermayer, Eva, Papageorghiou, Aris, Potter, Claire, Prefumo, Federico, Raio, Luigi, Richter, Jute, Sande, Ragnar Kvie, Schlembach, Dietmar, Schleußner, Ekkehard, Stampalija, Tamara, Thilaganathan, Basky, Townson, Julia, Valensise, Herbert, Visser, Gerard Ha, Wee, Ling, Wolf, Hans, Lees, Christoph C. TRUFFLE 2 Collaborators List: Andrea Smith, Andrew Sharp, Andy Simm, Angela Ramoni, Barry Lloyd, Bianca Masturzo, Christine Morfeld, Christopher Lloyd, Claudia Seidig, Danielle Thornton, Elena Mantovani, Emanuela Taricco, Emma Bertucci, Erich Cosmi, Eva Ostermayer, Ferenc Macsali, Francesca Ferrari, Francesco D'Antonio, Francesco Picciotto, Gareth Waring, Georgios Rembouskos, Giuseppe Cali, Giuseppe Rizzo, Grazia Maria Tiralongo, Ilaria Fantasia, Ilaria Giuditta Ramezzana, Ilenia Mappa, Ioannis Kyvernitakis, Iris Derwig, Iris Dressler-Steinbach, Jiří Vojěch, Jørgen Linde, Julia Binder, Karen Melchiorre, Kate Walker, Kinga Chalubinski, Kristiina Rull, Kristina Kernell, Lars Brodowski, Laura Sarno, Ligita Jokibkiene, Liina Rajasalu, Lina-Ana Fryszer, Louisa Jones, Magdalena Bednarek-Jędrzejek, Makrina Savvidou, Maria Stefopoulou, Marianna Rambaldi, Mark Kilby, Nia Jones, Nicola Fratelli, Nishigandh Deole, Patrick Greimel, Petra Pateisky, Pilar Palmrich, Ralf Schild, Roland Devlieger, Sabina Ondrová, Sarah Gumpert, Sasha Taylor, Saskia Schmidt, Sebastian Kwiatkowski, Serena Caterina, Serena Ottanelli, Serena Simeone, Sergio Ferrazzani, Silvia Salvi, Silvia Visentin, Sofia Amylidi-Mohr, Spyros Bakalis, Stefan Verlohren, Susanne Dargel, Sven Kehl, Tanja Groten, Tatjana Radaelli, Tinne Mesens, Tiziana Fanelli, Torbjørn Eggebø, Tullio Ghi, Tuuli Haabpiht, Wassim Hassan, Yvonne Heiman, Zulfiya Khodzhaeva, Baskaran Thilaganathan, Christoph Brezinka, Sanne Gordijn, Wessel Ganzevoort, Abin Thomas Andrea Smith, Abin Thomas |
| المساهمون: | Bronacha, Mylrea-Foley, Jim G, Thornton, Edward, Mullin, Neil, Marlow, Kurt, Hecher, Christina, Ammari, Birgit, Arabin, Astrid, Berger, Eva, Bergman, Amarnath, Bhide, Caterina, Bilardo, Julia, Binder, Andrew, Breeze, Jana, Brodszki, Pavel, Calda, Rebecca, Cannings-John, Andrej, Černý, Elena, Cesari, Irene, Cetin, Andrea, Dall'Asta, Anke, Diemert, Cathrine, Ebbing, Torbjørn, Eggebø, Ilaria, Fantasia, Enrico, Ferrazzi, Tiziana, Frusca, Tullio, Ghi, Jenny, Goodier, Patrick, Greimel, Wilfried, Gyselaer, Wassim, Hassan, Constantin, Von Kaisenberg, Alexey, Kholin, Philipp, Klaritsch, Ladislav, Krofta, Peter, Lindgren, Silvia, Lobmaier, Karel, Marsal, Giuseppe M, Maruotti, Federico, Mecacci, Kirsti, Myklestad, Raffaele, Napolitano, Eva, Ostermayer, Aris, Papageorghiou, Claire, Potter, Federico, Prefumo, Luigi, Raio, Jute, Richter, Ragnar Kvie, Sande, Dietmar, Schlembach, Ekkehard, Schleußner, Tamara, Stampalija, Basky, Thilaganathan, Julia, Townson, Herbert, Valensise, Gerard Ha, Visser, Ling, Wee, Hans, Wolf, Lees, TRUFFLE 2 Collaborators List: Andrea Smith, Christoph C., Sharp, Andrew, Simm, Andy, Ramoni, Angela, Lloyd, Barry, Masturzo, Bianca, Morfeld, Christine, Lloyd, Christopher, Seidig, Claudia, Thornton, Danielle, Mantovani, Elena, Taricco, Emanuela, Bertucci, Emma, Cosmi, Erich, Ostermayer, Eva, Macsali, Ferenc, Ferrari, Francesca, D'Antonio, Francesco, Picciotto, Francesco, Waring, Gareth, Rembouskos, Georgio, Cali, Giuseppe, Rizzo, Giuseppe, Maria Tiralongo, Grazia, Fantasia, Ilaria, Giuditta Ramezzana, Ilaria, Mappa, Ilenia, Kyvernitakis, Ioanni, Derwig, Iri, Dressler-Steinbach, Iri, Vojěch, Jiří, Linde, Jørgen, Binder, Julia, Melchiorre, Karen, Walker, Kate, Chalubinski, Kinga, Rull, Kristiina, Kernell, Kristina, Brodowski, Lar, Sarno, Laura, Jokibkiene, Ligita |
| سنة النشر: | 2022 |
| المجموعة: | Archivio della ricerca dell'Università di Modena e Reggio Emilia (Unimore: IRIS) |
| مصطلحات موضوعية: | fetal medicine, maternal medicine, ultrasonography, Cardiotocography, Child, Female, Fetal Growth Retardation, Fetal Weight, Heart Rate, Fetal, Human, Infant, Newborn, Pregnancy, Randomized Controlled Trials as Topic, Premature Birth, Prenatal |
| الوصف: | Introduction: Following the detection of fetal growth restriction, there is no consensus about the criteria that should trigger delivery in the late preterm period. The consequences of inappropriate early or late delivery are potentially important yet practice varies widely around the world, with abnormal findings from fetal heart rate monitoring invariably leading to delivery. Indices derived from fetal cerebral Doppler examination may guide such decisions although there are few studies in this area. We propose a randomised, controlled trial to establish the optimum method of timing delivery between 32 weeks and 36 weeks 6 days of gestation. We hypothesise that delivery on evidence of cerebral blood flow redistribution reduces a composite of perinatal poor outcome, death and short-term hypoxia-related morbidity, with no worsening of neurodevelopmental outcome at 2 years. Methods and analysis: Women with non-anomalous singleton pregnancies 32+0 to 36+6 weeks of gestation in whom the estimated fetal weight or abdominal circumference is <10th percentile or has decreased by 50 percentiles since 18-32 weeks will be included for observational data collection. Participants will be randomised if cerebral blood flow redistribution is identified, based on umbilical to middle cerebral artery pulsatility index ratio values. Computerised cardiotocography (cCTG) must show normal fetal heart rate short term variation (≥4.5 msec) and absence of decelerations at randomisation. Randomisation will be 1:1 to immediate delivery or delayed delivery (based on cCTG abnormalities or other worsening fetal condition). The primary outcome is poor condition at birth and/or fetal or neonatal death and/or major neonatal morbidity, the secondary non-inferiority outcome is 2-year infant general health and neurodevelopmental outcome based on the Parent Report of Children's Abilities-Revised questionnaire. Ethics and dissemination: The Study Coordination Centre has obtained approval from London-Riverside Research Ethics Committee (REC) and ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/35428631; info:eu-repo/semantics/altIdentifier/wos/WOS:000783842400035; volume:12; issue:4; firstpage:1; lastpage:8; numberofpages:8; journal:BMJ OPEN; http://hdl.handle.net/11380/1274158Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85128487699 |
| DOI: | 10.1136/bmjopen-2021-055543 |
| الإتاحة: | https://doi.org/10.1136/bmjopen-2021-055543Test http://hdl.handle.net/11380/1274158Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.93DB1F14 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/bmjopen-2021-055543 |
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