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A remote parent-led early intervention protocol to promote motor development in infants with congenital heart disease: a feasibility pilot study of a randomized clinical trial
Michelon RC, Lucchese-Lobato F
Developmental Neurorehabilitation 2024 Apr-May;27(3-4):134-144
clinical trial
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

This study evaluated the feasibility of a parent-led, home-based early intervention for motor development in infants with Congenital Heart Disease (CHD), part of a larger multicenter, single-blind randomized controlled trial (ClinicalTrials.gov NCT05907109). Parents, supported by remote specialists weekly, engaged in multidomain stimulation activities five days a week, for six months. Feasibility was assessed via parental questionnaires, adherence rates, and infant motor development assessments. Despite high dropout and mortality rates, results showed 80% adherence, 91% parental satisfaction, 75% availability, and 60% self-efficacy. No significant motor skill differences were noted between the intervention (IG; n = 19) and control groups (CG; n = 11) at six months, but the higher baseline risk in IG suggests promotion of motor skills in the intervention group. Future studies in Brazil might extend the study duration to address high dropout and mortality rates.

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