Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol

Autor: 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, TRUFFLE 2 Collaborators List: Andrea Smith, Christoph C., Andrew, Sharp, Andy, Simm, Angela, Ramoni, Barry, Lloyd, Bianca, Masturzo, Christine, Morfeld, Christopher, Lloyd, Claudia, Seidig, Danielle, Thornton, Elena, Mantovani, Emanuela, Taricco, Bertucci, Emma, Erich, Cosmi, Eva, Ostermayer, Ferenc, Macsali, Ferrari, Francesca, 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
Přispěvatelé: 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, Ari, 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, Han, Lees, Christoph C, Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), National Institute for Health Research
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: BMJ Open, 12(4):e055543. BMJ PUBLISHING GROUP
BMJ Open, 12(4):e055543. BMJ Publishing Group
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; ... (2022). Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol. BMJ open, 12(4), e055543. BMJ Publishing Group 10.1136/bmjopen-2021-055543
Mylrea-Foley, B, Thornton, J G, Mullins, E, Marlow, N, Hecher, K, Ammari, C, Arabin, B, Berger, A, Bergman, E, Bhide, A, Bilardo, C, Binder, J, Breeze, A, Brodszki, J, Calda, P, Cannings-John, R, Černý, A, Cesari, E, Cetin, I, Dall'asta, A, Diemert, A, Ebbing, C, Eggebø, T, Fantasia, I, Ferrazzi, E, Frusca, T, Ghi, T, Goodier, J, Greimel, P, Gyselaers, W, Hassan, W, von Kaisenberg, C, Kholin, A, Klaritsch, P, Krofta, L, Lindgren, P, Lobmaier, S, Marsal, K, Maruotti, G M, Mecacci, F, Myklestad, K, Napolitano, R, Ostermayer, E, Papageorghiou, A, Potter, C, Prefumo, F, Raio, L, Richter, J, Sande, R K, Schlembach, D, Schleußner, E, Stampalija, T, Thilaganathan, B, Townson, J, Valensise, H, Visser, G H A, Wee, L, Wolf, H & Lees, C C 2022, ' Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise : The TRUFFLE 2 randomised trial protocol ', BMJ Open, vol. 12, no. 4, e055543 . https://doi.org/10.1136/bmjopen-2021-055543
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2021-055543
Popis: IntroductionFollowing 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 analysisWomen with non-anomalous singleton pregnancies 32+0 to 36+6 weeks of gestation in whom the estimated fetal weight or abdominal circumference is Ethics and disseminationThe Study Coordination Centre has obtained approval from London-Riverside Research Ethics Committee (REC) and Health Regulatory Authority (HRA). Publication will be in line with NIHR Open Access policy.Trial registration numberMain sponsor: Imperial College London, Reference: 19QC5491. Funders: NIHR HTA, Reference: 127 976. Study coordination centre: Imperial College Healthcare NHS Trust, Du Cane Road, London, W12 0HS with Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University. IRAS Project ID: 266 400. REC reference: 20/LO/0031. ISRCTN registry: 76 016 200.
Databáze: OpenAIRE
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