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Multicenter Study
. 2019 Sep 10;19(1):326.
doi: 10.1186/s12887-019-1689-y.

Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol

I Ribera  1 , A Ruiz  1 , O Sánchez  1   2 , E Eixarch  3 , E Antolín  2   4 , E Gómez-Montes  2   5 , M Pérez-Cruz  2   3 , M Cruz-Lemini  1 , M Sanz-Cortés  3 , S Arévalo  1 , Q Ferrer  6 , E Vázquez  7 , L Vega  6 , P Dolader  6 , A Montoliu  8 , H Boix  9 , R V Simões  3 , N Masoller  3 , J Sánchez-de-Toledo  2   10 , M Comas  11 , J M Bartha  2   4 , A Galindo  2   5 , J M Martínez  3 , L Gómez-Roig  2   3 , F Crispi  3 , O Gómez  3 , E Carreras  1 , L Cabero  1 , E Gratacós  3 , E Llurba  12   13
Affiliations
Multicenter Study

Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol

I Ribera et al. BMC Pediatr. .

Abstract

Background: Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns. 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.

Methods: Eligible participants are women presenting at 20 to < 37 weeks of gestation carrying a fetus with CHD. Maternal/neonatal recordings are performed at regular intervals, from the fetal period to 24 months of age, and include: placental and fetal hemodynamics, fetal brain magnetic resonance imaging (MRI), functional echocardiography, cerebral oxymetry, electroencephalography and serum neurological and cardiac biomarkers. Neurodevelopmental assessment is planned at 12 months of age using the ages and stages questionnaire (ASQ) and at 24 months of age with the Bayley-III test. Target recruitment is at least 150 cases classified in three groups according to three main severe CHD groups: transposition of great arteries (TGA), Tetralogy of Fallot (TOF) and Left Ventricular Outflow Tract Obstruction (LVOTO).

Discussion: The results of NEURO-HEART study will provide the most comprehensive knowledge until date of children's neurologic prognosis in CHD and will have the potential for developing future clinical decisive tools and improving preventive strategies in CHD.

Trial registration: NCT02996630 , on 4th December 2016 (retrospectively registered).

Keywords: Cardiac function and fetal brain MR; Congenital heart disease; Neurodevelopment; Predictive markers.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

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Fig. 1
Study procedures flowchart
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References

    1. Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39:1890–1900. doi: 10.1016/S0735-1097(02)01886-7. - DOI - PubMed
    1. Moons P, Sluysmans T, De Wolf D, Massin M, Suys B, Benatar A, Gewillig M. Congenital heart disease in 111 225 births in Belgium: birth prevalence, treatment and survival in the 21s century. Acta Paediatr. 2009;98:472–477. doi: 10.1111/j.1651-2227.2008.01152.x. - DOI - PubMed
    1. Bakiler AR, Ozer EA, Kanik A, Kanit H, Aktas FN. Accuracy of prenatal diagnosis of congenital heart disease with fetal echocardiography. Fetal Diagn Ther. 2007;22:241–244. doi: 10.1159/000100782. - DOI - PubMed
    1. Majnemer A, Limperopoulos C, Shevell M, Rosenblatt B, Rohlicek C, Tchervenkov C. Long-term neuromotor outcome at school entry of infants with congenital heart defects requiring open-heart surgery. J Pediatr. 2006;148:72–77. doi: 10.1016/j.jpeds.2005.08.036. - DOI - PubMed
    1. Bellinger DC, Jonas RA, Rappaport LA, Wypij D, Wernovsky G, Kuban KCK, Barnes PD, Holmes GL, Hickey PR, Strand RD, Walsh AZ, Helmers SL, Constantinou JE, Carrazana EJ, Mayer JE, Hanley FL, Castaneda AR, Ware JH, Newburger JW. Developmental and neurologic status of children after heart surgery with hypothermic circulatory arrest or low-flow cardiopulmonary bypass. N Engl J Med. 1995;332:549–555. doi: 10.1056/NEJM199503023320901. - DOI - PubMed

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