An interventional study of Sonography and Magnetic Resonance Imaging in Congenital Heart Disease, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 1 site in Spain. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-19.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Diagnostic
Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns per year. Children with CHD are a known risk population for brain injury, with neurodevelopmental alterations shown over time in up to 50% of cases. No adequate description exists of the type of neurocognitive anomalies or risk factors associated with CHD, and consequently no prognostic markers that may allow identification of high-risk cases are available.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Pregnant patients carrying a healthy fetus. Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test.
Procedure: Sonography · Device: Magnetic Resonance Imaging · Other: Bailey Test · Procedure: cord blood sample
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.
Procedure: Sonography · Device: Magnetic Resonance Imaging · Other: Bailey Test · Procedure: Surgical intervention · Procedure: Brain monitoring · Procedure: cord blood sample
Fetal Ultrasound exploration
Fetal MRI for brain study
Neurodevelopment paediatric assessment test performed at 2 years of age.
Congenital Heart Disease repair
EEG and continuous brain oximetry before surgery.
Cord blood samples will be taken after birth in both groups.
Bailey-III test punctuation
Results in pediatric Bailey-III test scale
Time frame: 45 minutes
Biparietal diameter (mm)
Biparietal diameter (mm) measured with MRI
Time frame: one day
Lateral sulcus depth
Lateral sulcus depth (mm) measured with MRI
Time frame: one day
Cerebral insula
Insula (mm) measured with MRI
Time frame: one day
Brain biometries
Calcarine sulcus depth (mm)
Time frame: one day
Cerebral cingulata sulcus
Cingulata sulcus depth (mm) measured with MRI
Time frame: one day
Corpus callosum
Corpus callosum (mm) measured with MRI
Time frame: one day
Cerebellum
Cerebellum vermis (mm) measured with MRI
Time frame: one day
Umbilical doppler
Umbilical artery pulsatility index
Time frame: one day
Middle cerebral artery doppler
Middle cerebral artery pulsatility index
Time frame: one day
Angiogenic PLGF (placental growth factor)
Placental growth factor in maternal serum
Time frame: Two days
Angiogenic s-FLt (soluble fms-like tyrosine kinase)
Soluble fms-like tyrosine kinase factor in maternal serum
Time frame: Two days
Plan to share: No
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Hospital Universitari Vall d'Hebron Research Institute