Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol. Issue 4 (15th April 2022)

• Record Type: Journal Article
• Authors: 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;
• Other Names: author non-byline.; Smith Andrea author non-byline.; Sharp Andrew author non-byline.; Simm Andy author non-byline.; Ramoni Angela author non-byline.; Lloyd Barry author non-byline.; Masturzo Bianca author non-byline.; Morfeld Christine author non-byline.; Lloyd Christopher author non-byline.; Seidig Claudia author non-byline.; Thornton Danielle author non-byline.; Mantovani Elena author non-byline.; Taricco Emanuela author non-byline.; Bertucci Emma author non-byline.; Cosmi Erich author non-byline.; Ostermayer Eva author non-byline.; Macsali Ferenc author non-byline.; Ferrari Francesca author non-byline.; D'Antonio Francesco author non-byline.; Picciotto Francesco author non-byline.; Waring Gareth author non-byline.; Rembouskos Georgios author non-byline.; Cali Giuseppe author non-byline.; Rizzo Giuseppe author non-byline.; Tiralongo Grazia Maria author non-byline.; Fantasia Ilaria author non-byline.; Ramezzana Ilaria Giuditta author non-byline.; Mappa Ilenia author non-byline.; Kyvernitakis Ioannis author non-byline.; Derwig Iris author non-byline.; Dressler-Steinbach Iris author non-byline.; Vojěch Jiří author non-byline.; Linde Jørgen author non-byline.; Binder Julia author non-byline.; Melchiorre Karen author non-byline.; Walker Kate author non-byline.; Chalubinski Kinga author non-byline.; Rull Kristiina author non-byline.; Kernell Kristina author non-byline.; Brodowski Lars author non-byline.; Sarno Laura author non-byline.; Jokibkiene Ligita author non-byline.; Rajasalu Liina author non-byline.; Fryszer Lina-Ana author non-byline.; Jones Louisa author non-byline.; Bednarek-Jędrzejek Magdalena author non-byline.; Savvidou Makrina author non-byline.; Stefopoulou Maria author non-byline.; Rambaldi Marianna author non-byline.; Kilby Mark author non-byline.; Jones Nia author non-byline.; Fratelli Nicola author non-byline.; Deole Nishigandh author non-byline.; Greimel Patrick author non-byline.; Pateisky Petra author non-byline.; Palmrich Pilar author non-byline.; Schild Ralf author non-byline.; Devlieger Roland author non-byline.; Ondrová Sabina author non-byline.; Gumpert Sarah author non-byline.; Taylor Sasha author non-byline.; Schmidt Saskia author non-byline.; Kwiatkowski Sebastian author non-byline.; Caterina Serena author non-byline.; Ottanelli Serena author non-byline.; Simeone Serena author non-byline.; Ferrazzani Sergio author non-byline.; Salvi Silvia author non-byline.; Visentin Silvia author non-byline.; Amylidi-Mohr Sofia author non-byline.; Bakalis Spyros author non-byline.; Verlohren Stefan author non-byline.; Dargel Susanne author non-byline.; Kehl Sven author non-byline.; Groten Tanja author non-byline.; Radaelli Tatjana author non-byline.; Mesens Tinne author non-byline.; Fanelli Tiziana author non-byline.; Eggebø Torbjørn author non-byline.; Ghi Tullio author non-byline.; Haabpiht Tuuli author non-byline.; Hassan Wassim author non-byline.; Heiman Yvonne author non-byline.; Khodzhaeva Zulfiya author non-byline.; Thilaganathan Baskaran author non-byline.; Brezinka Christoph author non-byline.; Gordijn Sanne author non-byline.; Ganzevoort Wessel author non-byline.; Thomas Abin author non-byline.;
• Is Part Of: BMJ open. Volume 12:Issue 4(2022)
• Publication Date: 2022-04-15
• Subjects: fetal medicine -- maternal medicine -- ultrasonography; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-055543
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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 Health Regulatory Authority (HRA). Publication will be in line with NIHR Open Access policy. Trial registration number: Main 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.