Home based early intervention with CareToy-Revised in infants with early brain injury: a randomized controlled trial

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Introduction Intensive, family-centered early intervention (EI) may support neurodevelopment during a period of high neuroplasticity in infants with perinatal brain injury who are at high risk of cerebral palsy (CP). CareToy-Revised (CT-R) is a smart, home-based, parent-delivered system that provides individualized, goal-directed EI. Aims: To determine the effects of CT-R on early motor development of infants with brain injury, thus at high risk of developing CP, comparing it with another known EI, namely the Infant Massage (IM). Methods Thirty-eight infants with perinatal brain injury, at high risk of cerebral palsy (CT-R n = 19; IM n = 19) participated in this randomized and evaluator-blinded clinical trial ( ClinicalTrials.gov : NCT03211533; NCT03234959). Early motor development (primary outcome) was assessed using Infant Motor Profile (IMP) at baseline (T0) and post-intervention, immediately after the EI (T1), after 2 months (T2) and at 18 months of corrected age (T3). Secondary outcomes included assessments by Peabody Developmental Motor Scales, Second Edition (PDMS-2) and Teller Acuity Cards (TAC) at all time points and Bayley-III cognitive scale BSID-III at T0 and T3. Between-group differences at each time point were tested using the Mann–Whitney test, and longitudinal effects were evaluated using linear mixed-effects models adjusted for covariates. Results The groups presented no significant differences at baseline. At T1, the CT-R group showed significantly higher IMP raw scores for total score, symmetry, and performance than the IM group. For PDMS-2, TAC, and BSID-III cognition, no significant between-group differences were found. After adjustment for covariates, CT-R showed effectiveness at T1 across the IMP domains (total β = 5.506, 95% CI 4.23–6.78; variation β = 6.329, 4.24–8.42; symmetry β = 6.075, 3.79–8.36; performance β = 5.657, 3.49–7.82). At T2, effectiveness remained for the IMP total score ( β = 4.020, 2.76–5.28) and variation ( β = 5.503, 3.43–7.57). No significant Group × Time effects were observed at T3. Discussion CT-R significantly improved the early motor development of infants with early brain injury, supporting the potential value of intensive, individualized, home-based, and parent-delivered EI. Clinical Trial Registration NCT03234959 on ClinicalTrials.gov .

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