Status: Funded - Open
Improving neurodevelopment in children with congenital heart disease: An intervention study
Johanna Calderon, PhD, MS
BACKGROUND: Congenital heart disease (CHD) is the most common birth defect and neurodevelopmental dysfunction, particularly executive dysfunction, is the most frequent long-term morbidity in youth with CHD.
GAP: Deficits in executive function are at the heart of the neurodevelopmental phenotype in children and adolescents with CHD. The identification and treatment of neurodevelopmental morbidity constitute a primary aim in medical care and a public health priority as the number of individuals with CHD soars; however, to date, no study has investigated the efficacy of neurocognitive interventions aimed at preventing, reducing or compensating for these frequent morbidities.
HYPOTHESIS: Hypothesis 1: Adolescents who receive the intervention (intervention group), compared to a control group receiving standard of care, will display greater improvement from baseline to immediate post-treatment on all neurodevelopmental assessments. Hypothesis 2: Significant gains in neurodevelopmental scores will persist 3 months after the end of the intervention.
Hypothesis 3: Univentricular heart anatomy and/or a larger number of open-heart surgeries are associated with larger positive effects on neurodevelopment at immediate post-treatment and at 3-month follow-up in the intervention group.
METHODS: This is a single-center, single-blinded RCT of the efficacy of a computerized neurocognitive intervention in young adolescents with CHD after infant open-heart surgery. Adolescents with a diagnosis of critical CHD requiring open-heart surgery, aged between 13 and 16 years at the time of enrollment and followed-up at Boston Children’s Hospital, Department of Cardiology.
IMPACT: Our trial will (1) provide the foundation for a national multicenter RCT of interventions to improve neurodevelopment in youth with CHD; (2) provide insights into medical and surgical factors associated with treatment response to assist in targeting cost-effective interventions; (3) generate novel hypotheses regarding the neurodevelopmental plasticity following non-pharmacological interventions in children and adolescents with CHD.
Boston Children's Hospital