VISIBLE: Vision Intervention for Severely Impaired Babies: Learning through Enrichment-a study protocol

Abstract

Objective: Early perinatal brain injury results physical disability such as cerebral palsy (CP) and visual dysfunction such as cerebral visual impairment (CVI). The aim of this study is evaluate the efficacy of a vision aware early intervention program VISIBLE on the visual, motor and cognitive development and parent infant emotional and relational developmental outcomes. Design: Multi-site, pilot randomised control trial. Method: A total of 32 participants from Queensland, Sydney, Melbourne, Perth and Italy would be recruited for this study. After entering the study by 6 months corrected age infants will be randomly allocated to receive VISIBLE intervention or care as usual. This study involves 6-month fortnightly early vision-awareness and parent-directed environmental enrichment program for infants in the age group of 3-6 months with severe visual impairment (visual acuity <1 cycle/degree) and a diagnosis of CP or 'high risk of CP' (absent Fidgety GMs or low HINE score <57). Full ethical approval has been obtained and the VISIBLE study trial has been registered with Australian and New Zealand Clinical Trials registration: (ACTRN 12618000932268). The vision aware intervention will be delivered in the home environment by a VISIBLE trained therapist including environmental enrichment and modification, active motor and cognitive learning activities delivered by the parent using a coaching model. Results: The outcomes that will be analysed in this study are visual function using the Infant Battery for Vision Inventory, motor skills utilising the Peabody Development Scale, cognitive and social-emotional development utilising Bayley Scales of Infant and Toddler development and parent child engagement using the Emotional Availability Scales. The relationship between brain structure and functional indexes including neuroplasticity and vision and motor skills will also be analysed. Conclusion: This study will determine if infants receiving VISIBLE program should have superior visual behaviour, motor and cognitive scores at 12 months of age than those who received standard of care. It would be an intervention program that is feasible and acceptable to implement by the parents.L6316059322020-05-04 <br />