Assessing Neurodevelopment in Congenital Heart Disease. (NEUROHEART)
Abnormal Neurodevelopment Detection in Congenital Heart Disease: Predictive Methods Based on Prenatal and Postnatal Factors.
研究概览
地位
条件
详细说明
The main objectives of this study are: 1. to describe the neurodevelopmental outcome of patients with CHD at 24 months of age; 2. identify the subgroup with poorer outcome; and 3. evaluate the utility of fetal and postnatal diagnostic techniques for early detection of patients at risk for altered neurological outcomes.
Seven Spanish referral centers for CHD included in the research network on maternal and child health currently participating in this prospective multicentric case-control coordinated study. Fetuses with CHD (transposition of great arteries, tetralogy of Fallot, hypoplastic left heart syndrome and septal defects) will be studied from 24 weeks of gestation to 2 years of age. Diagnostic tests will be repeated throughout the study in all patients, from the fetal period to 24 months of age, and will include: fetal cerebral hemodynamic Doppler assessment, functional echocardiography, brain MRI, regional cerebral oxymetry, electroencephalography and serum neurological and cardiac biomarkers analysis. Neurodevelopmental assessment will be made at 12 months of age using the ages and stages questionnaire (ASQ) and at 24 months of age with the Bayley-III test. From this data, statistical analysis will select the most useful as predictors of damage; to be then combined and create algorithms for predicting brain damage and poor neurodevelopment. Once description has been made, we will proceed to identify amongst our results, children with the poorest neurological outcome and remark possible common prenatal and early life markers in them as well as the CHD severity they present.
While advances in early diagnosis and postnatal management have increased survival in CHD children, worrying long-term outcomes, particularly neurodevelopmental disability, have emerged as a key prognostic factor in the counseling of these pregnancies. Evidence available does not allow clinicians to assess on neurological prognosis although has opened up the possibility of finding prenatal markers of brain damage. Even though, no prospective studies have been performed until now. We present a multicentric prospective study able to recruit enough fetal CHD affected pregnancies to obtain neurological prognostic tools.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Irene Ribera, MD
- 电话号码:3086 934893000
- 邮箱:irene.ribera@vhir.org
研究联系人备份
- 姓名:Aina Ruiz, MD
- 电话号码:3086 934893000
- 邮箱:aruizrom@gmail.com
学习地点
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Barcelona、西班牙、08035
- 招聘中
- Hospital Universitari Vall d'Hebron
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接触:
- Irene Ribera, Dr
- 电话号码:3086 934893000
- 邮箱:irene.ribera@vhir.org
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接触:
- Elisa Llurba, Dr
- 电话号码:3086 934893000
- 邮箱:irene.ribera@vhir.org
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Single pregnancies
- Major Congenital Heart Disease
- Informed Consent Signed
Exclusion Criteria:
- Major extra-cardiac malformations
- Parental Refusal to participate
- Maternal Chronic Disease
- Multiple Pregnancies
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:Healthy fetuses
Pregnant patients carrying a healthy fetus.
Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test.
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Fetal Ultrasound exploration
Fetal MRI for brain study
Neurodevelopment paediatric assessment test performed at 2 years of age.
Cord blood samples will be taken after birth in both groups.
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其他:Congenital Hearth Disease
Pregnant patients carrying a fetus with a moderate-severe congenital heart disease Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging, Surgical intervention, brain monitoring and bailey test.
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Fetal Ultrasound exploration
Fetal MRI for brain study
Neurodevelopment paediatric assessment test performed at 2 years of age.
Cord blood samples will be taken after birth in both groups.
Congenital Heart Disease repair
EEG and continuous brain oximetry before surgery.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Bailey-III test punctuation
大体时间:45 minutes
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Results in pediatric Bailey-III test scale
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45 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Biparietal diameter (mm)
大体时间:one day
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Biparietal diameter (mm) measured with MRI
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one day
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Lateral sulcus depth
大体时间:one day
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Lateral sulcus depth (mm) measured with MRI
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one day
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Cerebral insula
大体时间:one day
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Insula (mm) measured with MRI
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one day
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Brain biometries
大体时间:one day
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Calcarine sulcus depth (mm)
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one day
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Cerebral cingulata sulcus
大体时间:one day
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Cingulata sulcus depth (mm) measured with MRI
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one day
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Corpus callosum
大体时间:one day
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Corpus callosum (mm) measured with MRI
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one day
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Cerebellum
大体时间:one day
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Cerebellum vermis (mm) measured with MRI
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one day
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Umbilical doppler
大体时间:one day
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Umbilical artery pulsatility index
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one day
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Middle cerebral artery doppler
大体时间:one day
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Middle cerebral artery pulsatility index
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one day
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Angiogenic PLGF (placental growth factor)
大体时间:Two days
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Placental growth factor in maternal serum
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Two days
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Angiogenic s-FLt (soluble fms-like tyrosine kinase)
大体时间:Two days
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Soluble fms-like tyrosine kinase factor in maternal serum
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Two days
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合作者和调查者
合作者
调查人员
- 研究主任:Elisa Llurba, MD, PhD、Hospital Universitari Vall d'Hebron
出版物和有用的链接
一般刊物
- Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
- Bellinger DC, Jonas RA, Rappaport LA, Wypij D, Wernovsky G, Kuban KC, Barnes PD, Holmes GL, Hickey PR, Strand RD, et al. Developmental and neurologic status of children after heart surgery with hypothermic circulatory arrest or low-flow cardiopulmonary bypass. N Engl J Med. 1995 Mar 2;332(9):549-55. doi: 10.1056/NEJM199503023320901.
- Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.
- Masoller N, Martinez JM, Gomez O, Bennasar M, Crispi F, Sanz-Cortes M, Egana-Ugrinovic G, Bartrons J, Puerto B, Gratacos E. Evidence of second-trimester changes in head biometry and brain perfusion in fetuses with congenital heart disease. Ultrasound Obstet Gynecol. 2014 Aug;44(2):182-7. doi: 10.1002/uog.13373. Epub 2014 Jul 8.
- Ruiz A, Cruz-Lemini M, Masoller N, Sanz-Cortes M, Ferrer Q, Ribera I, Martinez JM, Crispi F, Arevalo S, Gomez O, Perez-Hoyos S, Carreras E, Gratacos E, Llurba E. Longitudinal changes in fetal biometry and cerebroplacental hemodynamics in fetuses with congenital heart disease. Ultrasound Obstet Gynecol. 2017 Mar;49(3):379-386. doi: 10.1002/uog.15970.
- Ribera I, Ruiz A, Sanchez O, Eixarch E, Antolin E, Gomez-Montes E, Perez-Cruz M, Cruz-Lemini M, Sanz-Cortes M, Arevalo S, Ferrer Q, Vazquez E, Vega L, Dolader P, Montoliu A, Boix H, Simoes RV, Masoller N, Sanchez-de-Toledo J, Comas M, Bartha JM, Galindo A, Martinez JM, Gomez-Roig L, Crispi F, Gomez O, Carreras E, Cabero L, Gratacos E, Llurba E. Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol. BMC Pediatr. 2019 Sep 10;19(1):326. doi: 10.1186/s12887-019-1689-y.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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