Assessing Neurodevelopment in Congenital Heart Disease.
- Conditions
- Congenital Heart Disease
- Interventions
- Procedure: SonographyDevice: Magnetic Resonance ImagingOther: Bailey TestProcedure: Surgical interventionProcedure: cord blood sampleProcedure: Brain monitoring
- Registration Number
- NCT02996630
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 250
- Single pregnancies
- Major Congenital Heart Disease
- Informed Consent Signed
- Major extra-cardiac malformations
- Parental Refusal to participate
- Maternal Chronic Disease
- Multiple Pregnancies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy fetuses Sonography Pregnant patients carrying a healthy fetus. Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test. Healthy fetuses Magnetic Resonance Imaging Pregnant patients carrying a healthy fetus. Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test. Congenital Hearth Disease Sonography 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. Congenital Hearth Disease Surgical intervention 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. Healthy fetuses cord blood sample Pregnant patients carrying a healthy fetus. Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test. Healthy fetuses Bailey Test Pregnant patients carrying a healthy fetus. Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test. Congenital Hearth Disease Bailey Test 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. Congenital Hearth Disease Brain monitoring 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. Congenital Hearth Disease Magnetic Resonance Imaging 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. Congenital Hearth Disease 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.
- Primary Outcome Measures
Name Time Method Bailey-III test punctuation 45 minutes Results in pediatric Bailey-III test scale
- Secondary Outcome Measures
Name Time Method Brain biometries one day Calcarine sulcus depth (mm)
Cerebral insula one day Insula (mm) measured with MRI
Cerebellum one day Cerebellum vermis (mm) measured with MRI
Umbilical doppler one day Umbilical artery pulsatility index
Biparietal diameter (mm) one day Biparietal diameter (mm) measured with MRI
Middle cerebral artery doppler one day Middle cerebral artery pulsatility index
Lateral sulcus depth one day Lateral sulcus depth (mm) measured with MRI
Corpus callosum one day Corpus callosum (mm) measured with MRI
Angiogenic PLGF (placental growth factor) Two days Placental growth factor in maternal serum
Cerebral cingulata sulcus one day Cingulata sulcus depth (mm) measured with MRI
Angiogenic s-FLt (soluble fms-like tyrosine kinase) Two days Soluble fms-like tyrosine kinase factor in maternal serum
Trial Locations
- Locations (1)
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain