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Assessing Neurodevelopment in Congenital Heart Disease. (NEUROHEART)

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ClinicalTrials.gov Identifier: NCT02996630
Recruitment Status : Unknown
Verified October 2016 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Collaborators:
Hospital Sant Joan de Deu
Hospital Universitario La Paz
Hospital Universitario 12 de Octubre
Hospital General Universitario Gregorio Marañon
Institut Universitari Dexeus
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Procedure: Sonography Device: Magnetic Resonance Imaging Other: Bailey Test Procedure: Surgical intervention Procedure: Brain monitoring Procedure: cord blood sample Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Abnormal Neurodevelopment Detection in Congenital Heart Disease: Predictive Methods Based on Prenatal and Postnatal Factors.
Study Start Date : May 2013
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Healthy fetuses
Pregnant patients carrying a healthy fetus. Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test.
Procedure: Sonography
Fetal Ultrasound exploration

Device: Magnetic Resonance Imaging
Fetal MRI for brain study

Other: Bailey Test
Neurodevelopment paediatric assessment test performed at 2 years of age.

Procedure: 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.
Procedure: Sonography
Fetal Ultrasound exploration

Device: Magnetic Resonance Imaging
Fetal MRI for brain study

Other: Bailey Test
Neurodevelopment paediatric assessment test performed at 2 years of age.

Procedure: Surgical intervention
Congenital Heart Disease repair

Procedure: Brain monitoring
EEG and continuous brain oximetry before surgery.

Procedure: cord blood sample
Cord blood samples will be taken after birth in both groups.




Primary Outcome Measures :
  1. Bailey-III test punctuation [ Time Frame: 45 minutes ]
    Results in pediatric Bailey-III test scale


Secondary Outcome Measures :
  1. Biparietal diameter (mm) [ Time Frame: one day ]
    Biparietal diameter (mm) measured with MRI

  2. Lateral sulcus depth [ Time Frame: one day ]
    Lateral sulcus depth (mm) measured with MRI

  3. Cerebral insula [ Time Frame: one day ]
    Insula (mm) measured with MRI

  4. Brain biometries [ Time Frame: one day ]
    Calcarine sulcus depth (mm)

  5. Cerebral cingulata sulcus [ Time Frame: one day ]
    Cingulata sulcus depth (mm) measured with MRI

  6. Corpus callosum [ Time Frame: one day ]
    Corpus callosum (mm) measured with MRI

  7. Cerebellum [ Time Frame: one day ]
    Cerebellum vermis (mm) measured with MRI

  8. Umbilical doppler [ Time Frame: one day ]
    Umbilical artery pulsatility index

  9. Middle cerebral artery doppler [ Time Frame: one day ]
    Middle cerebral artery pulsatility index

  10. Angiogenic PLGF (placental growth factor) [ Time Frame: Two days ]
    Placental growth factor in maternal serum

  11. Angiogenic s-FLt (soluble fms-like tyrosine kinase) [ Time Frame: Two days ]
    Soluble fms-like tyrosine kinase factor in maternal serum



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996630


Contacts
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Contact: Irene Ribera, MD 934893000 ext 3086 irene.ribera@vhir.org
Contact: Aina Ruiz, MD 934893000 ext 3086 aruizrom@gmail.com

Locations
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Spain
Hospital Universitari Vall d'Hebrón Recruiting
Barcelona, Spain, 08035
Contact: Irene Ribera, Dr    934893000 ext 3086    irene.ribera@vhir.org   
Contact: Elisa Llurba, Dr    934893000 ext 3086    irene.ribera@vhir.org   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Hospital Sant Joan de Deu
Hospital Universitario La Paz
Hospital Universitario 12 de Octubre
Hospital General Universitario Gregorio Marañon
Institut Universitari Dexeus
Investigators
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Study Director: Elisa Llurba, MD, PhD Hospital Universitari Vall d'Hebrón

Publications of Results:
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02996630     History of Changes
Other Study ID Numbers: PR(AMI)317/2012
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
LVOTO
Fallot
Great Arteries Transposition

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities