Assessing Neurodevelopment in Congenital Heart Disease.

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.

Conditions

• Congenital Heart Disease

Interventions

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.

Sponsors & Collaborators

• Hospital Sant Joan de Deu

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Fundacion Dexeus

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Elisa Llurba, MD, PhD · Hospital Universitari Vall d'Hebrón

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2017-05-31

Completion

2018-05-31

Countries

• Spain

Study Locations