Assessing Neurodevelopment in Congenital Heart Disease.
NCT ID: NCT02996630
Last Updated: 2016-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2013-05-31
2018-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy fetuses
Pregnant patients carrying a healthy fetus. Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test.
Sonography
Fetal Ultrasound exploration
Magnetic Resonance Imaging
Fetal MRI for brain study
Bailey Test
Neurodevelopment paediatric assessment test performed at 2 years of age.
cord blood sample
Cord blood samples will be taken after birth in both groups.
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.
Sonography
Fetal Ultrasound exploration
Magnetic Resonance Imaging
Fetal MRI for brain study
Bailey Test
Neurodevelopment paediatric assessment test performed at 2 years of age.
Surgical intervention
Congenital Heart Disease repair
Brain monitoring
EEG and continuous brain oximetry before surgery.
cord blood sample
Cord blood samples will be taken after birth in both groups.
Interventions
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Sonography
Fetal Ultrasound exploration
Magnetic Resonance Imaging
Fetal MRI for brain study
Bailey Test
Neurodevelopment paediatric assessment test performed at 2 years of age.
Surgical intervention
Congenital Heart Disease repair
Brain monitoring
EEG and continuous brain oximetry before surgery.
cord blood sample
Cord blood samples will be taken after birth in both groups.
Eligibility Criteria
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Inclusion Criteria
* Major Congenital Heart Disease
* Informed Consent Signed
Exclusion Criteria
* Parental Refusal to participate
* Maternal Chronic Disease
* Multiple Pregnancies
FEMALE
Yes
Sponsors
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Hospital Sant Joan de Deu
OTHER
Hospital Universitario La Paz
OTHER
Hospital Universitario 12 de Octubre
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Fundacion Dexeus
OTHER
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Elisa Llurba, MD, PhD
Role: STUDY_DIRECTOR
Hospital Universitari Vall d'Hebrón
Locations
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Hospital Universitari Vall d'Hebrón
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Irene Ribera, Dr
Role: primary
Elisa Llurba, Dr
Role: backup
References
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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.
Other Identifiers
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PR(AMI)317/2012
Identifier Type: -
Identifier Source: org_study_id