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

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

SUBMITTER: Ribera I

PROVIDER: S-EPMC6737686 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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

Ribera I I Ruiz A A Sánchez O O Eixarch E E Antolín E E Gómez-Montes E E Pérez-Cruz M M Cruz-Lemini M M Sanz-Cortés M M Arévalo S S Ferrer Q Q Vázquez E E Vega L L Dolader P P Montoliu A A Boix H H Simões R V RV Masoller N N Sánchez-de-Toledo J J Comas M M Bartha J M JM Galindo A A Martínez J M JM Gómez-Roig L L Crispi F F Gómez O O Carreras E E Cabero L L Gratacós E E Llurba E E

BMC pediatrics 20190910 1

<h4>Background</h4>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.<h4>Methods</h4>Eligible participants are women presenting at 20 to < 37 weeks of gestation carrying a fetus with CHD. Mate ...[more]

PMID: 31506079

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Project description:OBJECTIVES:To assess neurodevelopmental outcomes among participants with biliary atresia with their native liver at ages 12 months (group 1) and 24 months (group 2), and to evaluate variables predictive of neurodevelopmental impairment. STUDY DESIGN:Participants enrolled in a prospective, longitudinal, multicenter study underwent neurodevelopmental testing with either the Bayley Scales of Infant Development, 2nd edition, or Bayley Scales of Infant and Toddler Development, 3rd edition. Scores (normative mean?=?100?±?15) were categorized as ?100, 85-99, and <85 for ?2 analysis. Risk for neurodevelopmental impairment (defined as ?1 score of <85 on the Bayley Scales of Infant Development, 2nd edition, or Bayley Scales of Infant and Toddler Development, 3rd edition, scales) was analyzed using logistic regression. RESULTS:There were 148 children who completed 217 Bayley Scales of Infant and Toddler Development, 3rd edition, examinations (group 1, n?=?132; group 2, n?=?85). Neurodevelopmental score distributions significantly shifted downward compared with test norms at 1 and 2 years of age. Multivariate analysis identified ascites (OR,?3.17; P?=?.01) and low length z-scores at time of testing (OR,?0.70; P?<?.04) as risk factors for physical/motor impairment; low weight z-score (OR,?0.57; P?=?.001) and ascites (OR,?2.89; P?=?.01) for mental/cognitive/language impairment at 1 year of age. An unsuccessful hepatoportoenterostomy was predictive of both physical/motor (OR,?4.88; P?<?.02) and mental/cognitive/language impairment (OR,?4.76; P?=?.02) at 2 years of age. CONCLUSION:Participants with biliary atresia surviving with native livers after hepatoportoenterostomy are at increased risk for neurodevelopmental delays at 12 and 24 months of age. Those with unsuccessful hepatoportoenterostomy are >4 times more likely to have neurodevelopmental impairment compared with those with successful hepatoportoenterostomy. Growth delays and/or complications indicating advanced liver disease should alert clinicians to the risk for neurodevelopmental delays, and expedite appropriate interventions. TRIAL REGISTRATION:Clinicaltrials.gov: NCT00061828 and NCT00294684.

Project description:IntroductionExecutive function (EF) impairments are among the most prevalent neurodevelopmental morbidities in youth with congenital heart disease (CHD). To date, no studies have investigated the efficacy of cognitive interventions to improve EF outcomes in children with CHD.Methods and analysisThis is a single-centre, single-blinded, two-arm randomised controlled trial to test the efficacy of Cogmed Working Memory Training (Cogmed) versus standard of care in children with CHD after open-heart surgery in infancy. Participants will consist of 100 children with CHD aged 7-12 years who underwent open-heart surgery before the age of 12 months. Participants are randomly allocated to either an intervention group including training on the home-based Cogmed intervention for a duration of approximately 5 weeks or a control group who receive the standard of care. We will evaluate the efficacy of Cogmed at post-treatment and 3 months after completion of the intervention. Baseline, post-treatment and 3-month follow-up assessments will include specific measures of EF, cognitive and social functioning, and attention deficit hyperactivity disorder (ADHD) symptoms. The primary outcome of this study is the change in standardised mean score on the List Sorting Working Memory test from the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function. Secondary outcomes include measures of social skills, inhibitory control, cognitive flexibility and behavioural EF as well as ADHD symptoms as measured by the Behavior Rating Inventory of Executive Function, Second Edition, and the Conners Third Edition. The efficacy of the intervention will be evaluated by comparing within-subject differences (baseline to post-treatment, baseline to 3-month follow-up) between the two groups using an intention-to-treat analysis.Ethics and disseminationThis study has received Institutional Review Board (IRB) approval from Boston's Children's Hospital IRB (P00022440) and the Human Protection Agency from the US Department of Defense.Trial registration numberNCT03023644; Pre-results.

Dataset Information

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

Publications

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

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