Health-related quality of life (HRQoL) in toddlers with congenital heart disease (CHD) remains insufficiently characterized, particularly regarding the respective contributions of cardiac severity and neurodevelopmental functioning.

In this cross-sectional study, 287 children aged 2–4 years (133 with CHD and 154 healthy controls) were assessed using the PedsQL™ 4.0 Generic Core Scales (parent proxy-report). Executive functioning was evaluated using the BRIEF Global Executive Composite score. Clinicaltrials.gov ( NCT04812210 ).

Compared with controls, children with CHD had lower overall HRQoL as reported by mothers (80.7 ± 14.8 vs 85.0 ± 11.4, P < 0.001) and fathers (82.8 ± 13.6 vs 85.9 ± 11.0, P = 0.04). Physical functioning did not differ significantly between groups, whereas emotional, social, and school functioning were significantly lower in the CHD group. Within CHD, lower HRQoL was associated with greater disease burden, including single ventricle physiology and markers of medical complexity. Executive functioning was independently associated with HRQoL in multivariable analyses: higher executive difficulties were consistently related to lower HRQoL in both maternal and paternal reports. Agreement between caregivers was good (ICC 0.73–0.77 for total score).

In toddlers with CHD, overall HRQoL is modestly reduced compared with peers, primarily driven by psychosocial rather than physical dimensions. Beyond cardiac severity, executive functioning emerges as a central correlate of early well-being. These findings highlight the importance of integrating neurodevelopmental evaluation into early CHD follow-up and suggest that HRQoL in early childhood reflects broader developmental functioning in addition to medical status.