Perinatal and 2-year neurodevelopmental outcome in late preterm fetal: the TRUFFLE 2 randomised trial protocolcompromise
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Perinatal and 2-year neurodevelopmental outcome in late preterm fetal: the TRUFFLE 2 randomised trial protocolcompromise. / 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 Group.
In: BMJ OPEN, Vol. 12, No. 4, e055543, 15.04.2022.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Perinatal and 2-year neurodevelopmental outcome in late preterm fetal: the TRUFFLE 2 randomised trial protocolcompromise
AU - Mylrea-Foley, Bronacha
AU - Thornton, Jim G
AU - Mullins, Edward
AU - Marlow, Neil
AU - Hecher, Kurt
AU - Ammari, Christina
AU - Arabin, Birgit
AU - Berger, Astrid
AU - Bergman, Eva
AU - Bhide, Amarnath
AU - Bilardo, Caterina
AU - Binder, Julia
AU - Breeze, Andrew
AU - Brodszki, Jana
AU - Calda, Pavel
AU - Cannings-John, Rebecca
AU - Černý, Andrej
AU - Cesari, Elena
AU - Cetin, Irene
AU - Dall'Asta, Andrea
AU - Diemert, Anke
AU - Ebbing, Cathrine
AU - Eggebø, Torbjørn
AU - Fantasia, Ilaria
AU - Ferrazzi, Enrico
AU - Frusca, Tiziana
AU - Ghi, Tullio
AU - Goodier, Jenny
AU - Greimel, Patrick
AU - Gyselaers, Wilfried
AU - Hassan, Wassim
AU - Von Kaisenberg, Constantin
AU - Kholin, Alexey
AU - Klaritsch, Philipp
AU - Krofta, Ladislav
AU - Lindgren, Peter
AU - Lobmaier, Silvia
AU - Marsal, Karel
AU - Maruotti, Giuseppe M
AU - Mecacci, Federico
AU - Myklestad, Kirsti
AU - Napolitano, Raffaele
AU - Ostermayer, Eva
AU - Papageorghiou, Aris
AU - Potter, Claire
AU - Prefumo, Federico
AU - Raio, Luigi
AU - Richter, Jute
AU - Sande, Ragnar Kvie
AU - Schlembach, Dietmar
AU - Schleußner, Ekkehard
AU - Stampalija, Tamara
AU - Thilaganathan, Basky
AU - Townson, Julia
AU - Valensise, Herbert
AU - Visser, Gerard Ha
AU - Wee, Ling
AU - Wolf, Hans
AU - Lees, Christoph C
AU - Truffle-2 Group
N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
PY - 2022/4/15
Y1 - 2022/4/15
N2 - 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.
AB - 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.
KW - Cardiotocography
KW - Child
KW - Female
KW - Fetal Growth Retardation
KW - Fetal Weight
KW - Heart Rate, Fetal/physiology
KW - Humans
KW - Infant
KW - Infant, Newborn
KW - Pregnancy
KW - Premature Birth
KW - Randomized Controlled Trials as Topic
KW - Ultrasonography, Prenatal
U2 - 10.1136/bmjopen-2021-055543
DO - 10.1136/bmjopen-2021-055543
M3 - SCORING: Journal article
C2 - 35428631
VL - 12
JO - BMJ OPEN
JF - BMJ OPEN
SN - 2044-6055
IS - 4
M1 - e055543
ER -