2 Year Neurodevelopmental and Intermediate Perinatal Outcomes in Infants With Very Preterm Fetal Growth Restriction (TRUFFLE): A Randomised Trial
| العنوان: | 2 Year Neurodevelopmental and Intermediate Perinatal Outcomes in Infants With Very Preterm Fetal Growth Restriction (TRUFFLE): A Randomised Trial |
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| المؤلفون: | Lees, Christoph C., Marlow, Neil, Van Wassenaer-Leemhuis, Aleid, Arabin, Birgit, Bilardo, Caterina M., Brezinka, Christoph, Calvert, Sandra, Derks, Jan B., Diemert, Anke, Duvekot, Johannes J., Ferrazzi, Enrico, Frusca, Tiziana, Ganzevoort, Wessel, Hecher, Kurt, Martinelli, Pasquale, Ostermayer, Eva, Papageorghiou, Aris T., Schlembach, Dietmar, Schneider, K. T M, Thilaganathan, Baskaran, Todros, Tullia, Valcamonico, Adriana, Visser, Gerard H A, Wolf, Hans, Aktas, Ayse, Borgione, Silvia, Chaoui, Rabih, Cornette, Jerome M J, Diehl, Thilo, Van Eyck, Jim, Fratelli, Nicola, Van Haastert, Inge Lot, Lobmaier, Silvia, Lopriore, Enrico, Missfelder-Lobos, Hannah, Mansi, Giuseppina, Martelli, Paola, Maso, Gianpaolo, Maurer-Fellbaum, Ute, Van Charante, Nico Mensing, De Tollenaer, Susanne Mulder, Napolitano, Raffaele, Oberto, Manuela, Oepkes, Dick, Ogge, Giovanna, Van Der Post, Joris, Prefumo, Federico, Preston, Lucy, Raimondi, Francesco, Reiss, Irwin K M, Scheepers, H. C J, Schuit, Ewoud, Skabar, Aldo, Spaanderman, Marc, Weisglas-Kuperus, Nynke, Zimmermann, Andrea, Moore, Tamanna, Johnson, Samantha, Rigano, Serena |
| المساهمون: | Other Research, Neonatology, Other departments, Amsterdam Public Health, Obstetrics and Gynaecology, Obstetrics and gynaecology, Reproductive Origins of Adult Health and Disease (ROAHD), RS: GROW - Developmental Biology, RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), APH - Amsterdam Public Health, ARD - Amsterdam Reproduction and Development, Christoph C., Lee, Neil, Marlow, Aleid van Wassenaer, Leemhui, Birgit, Arabin, Caterina M., Bilardo, Christoph, Brezinka, Sandra, Calvert, Jan B., Derk, Anke, Diemert, Johannes J., Duvekot, Enrico, Ferrazzi, Tiziana, Frusca, Wessel, Ganzevoort, Kurt, Hecher, Martinelli, Pasquale, Eva, Ostermayer, Aris T., Papageorghiou, Dietmar, Schlembach, K. T. M., Schneider, Baskaran, Thilaganathan, Tullia, Todro, Adriana, Valcamonico, Gerard H. A., Visser, Hans, Wolf, for the TRUFFLE study, group, Borgione, Silvia, Fratelli, Nicola, Lobmaier, Silvia, Lopriore, Enrico, Mansi, Giuseppina, Martelli, Paola, Maso, Gianpaolo, Napolitano, Raffaele, Oberto, Manuela, Prefumo, Federico, Raimondi, Francesco, Rigano, Serena, Obstetrics & Gynecology |
| المصدر: | Obstetrical & gynecological survey, 70(9), 555-557. Lippincott Williams and Wilkins Obstetrical and Gynecological Survey, 70(9), 555-557. Lippincott Williams and Wilkins Obstetrical & Gynecological Survey, 70(9), 555-557. LIPPINCOTT WILLIAMS & WILKINS Lancet, 385(9983), 2162-2172. Elsevier Science The Lancet, 385(9983), 2162-2172. ELSEVIER SCIENCE INC The Lancet, 385(9983), 2162. Elsevier Limited Lancet, 385(9983), 2162-2172. Elsevier Limited Lees, C C, Marlow, N, Van Wassenaer-Leemhuis, A, Arabin, B, Bilardo, C M, Brezinka, C, Calvert, S, Derks, J B, Diemert, A, Duvekot, J J, Ferrazzi, E, Frusca, T, Ganzevoort, W, Hecher, K, Martinelli, P, Ostermayer, E, Papageorghiou, A T, Schlembach, D, Schneider, K T M, Thilaganathan, B, Todros, T, Valcamonico, A, Visser, G H A & Wolf, H 2015, ' 2 year neurodevelopmental and intermediate perinatal outcomes in infants with very preterm fetal growth restriction (TRUFFLE) : A randomised trial ', Obstetrical and Gynecological Survey, vol. 70, no. 9, pp. 555-557 . https://doi.org/10.1097/01.ogx.0000471592.76233.5dTest Scopus-Elsevier Lancet (UK), 385(9983), 2162-2172. Elsevier Ltd. |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Male, Percentile, Pediatrics, Cardiotocography, CHILDREN, Umbilical Arteries, law.invention, Primary outcome, Randomized controlled trial, Heart Rate, law, Central Nervous System Diseases, Pregnancy, Fetal growth, Clinical endpoint, Prenatal, GESTATION, Child, PREDICTORS, Non-U.S. Gov't, Ultrasonography, Medicine(all), Fetal Growth Retardation, medicine.diagnostic_test, Medicine (all), Research Support, Non-U.S. Gov't, Pregnancy Outcome, Obstetrics and Gynecology, Gestational age, Pulsed, General Medicine, Heart Rate, Fetal, Very preterm, Neonatal morbidity, DOPPLER, Europe, Multicenter Study, PREECLAMPSIA, Ultrasonography, Doppler, Pulsed, Child, Preschool, Infant, Extremely Premature, Randomized Controlled Trial, Gestation, Female, Gestational Age, Humans, Infant, Newborn, Ultrasonography, Prenatal, INTERVENTION, Ductus venosus, Human, Reversed flow, medicine.medical_specialty, Extremely Premature, Research Support, PARAMETERS, Fetal, AGE, HEART-RATE VARIATION, SDG 3 - Good Health and Well-being, medicine, Journal Article, Preschool, Fetus, Intention-to-treat analysis, business.industry, RETARDED FETUSES, Infant, Newborn, medicine.disease, Umbilical Arterie, Central Nervous System Disease, business |
| الوصف: | No consensus exists for the best way to monitor and when to trigger delivery in mothers of babies with fetal growth restriction. We aimed to assess whether changes in the fetal ductus venosus Doppler waveform (DV) could be used as indications for delivery instead of cardiotocography short-term variation (STV). In this prospective, European multicentre, unblinded, randomised study, we included women with singleton fetuses at 26-32 weeks of gestation who had very preterm fetal growth restriction (ie, low abdominal circumference [ 95th percentile]). We randomly allocated women 1:1:1, with randomly sized blocks and stratified by participating centre and gestational age ( 95th percentile; DV p95), or late DV changes (A wave [the deflection within the venous waveform signifying atrial contraction] at or below baseline; DV no A). The primary outcome was survival without cerebral palsy or neurosensory impairment, or a Bayley III developmental score of less than 85, at 2 years of age. We assessed outcomes in surviving infants with known outcomes at 2 years. We did an intention to treat study for all participants for whom we had data. Safety outcomes were deaths in utero and neonatal deaths and were assessed in all randomly allocated women. This study is registered with ISRCTN, number 56204499. Between Jan 1, 2005 and Oct 1, 2010, 503 of 542 eligible women were randomly allocated to monitoring groups (166 to CTG STV, 167 to DV p95, and 170 to DV no A). The median gestational age at delivery was 30·7 weeks (IQR 29·1-32·1) and mean birthweight was 1019 g (SD 322). The proportion of infants surviving without neuroimpairment did not differ between the CTG STV (111 [77%] of 144 infants with known outcome), DV p95 (119 [84%] of 142), and DV no A (133 [85%] of 157) groups (ptrend=0·09). 12 fetuses (2%) died in utero and 27 (6%) neonatal deaths occurred. Of survivors, more infants where women were randomly assigned to delivery according to late ductus changes (133 [95%] of 140, 95%, 95% CI 90-98) were free of neuroimpairment when compared with those randomly assigned to CTG (111 [85%] of 131, 95% CI 78-90; p=0.005), but this was accompanied by a non-significant increase in perinatal and infant mortality. Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint, timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at 2 years of age. ZonMw, The Netherlands and Dr Hans Ludwig Geisenhofer Foundation, Germany |
| وصف الملف: | image/pdf |
| اللغة: | English |
| تدمد: | 0029-7828 0140-6736 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b838b1b63c768bb70411385d90c06a44Test https://doi.org/10.1097/01.ogx.0000471592.76233.5dTest |
| حقوق: | RESTRICTED |
| رقم الانضمام: | edsair.doi.dedup.....b838b1b63c768bb70411385d90c06a44 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 00297828 01406736 |
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