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Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) - protocol of a feasibility
Andrea Guzzetta1,2, Ada Bancale2, Anna Bedoshvili3,4
1Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy a.guzzetta@inpe.unipi.it.
Insights
This pilot study assesses the feasibility of the VISIBLE intervention for infants with cerebral vision impairment (CVI). The program aims to improve vision and development through parent-directed enrichment, offering hope for early intervention in cerebral palsy (CP).
Area of Science:
- Pediatric rehabilitation
- Developmental neuroscience
- Ophthalmology
Background:
- Visual impairment affects 40-50% of children with cerebral palsy (CP).
- Vision difficulties in CP are often under-recognized and undertreated, necessitating evidence-based interventions.
- Cerebral vision impairment (CVI) requires targeted support for infants and toddlers.
Purpose of the Study:
- To determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) program.
- To estimate the preliminary effects of the VISIBLE intervention on infant visual functions and early development.
- To compare the VISIBLE intervention with standard community-based care (SCC) for infants at risk of CP.
Main Methods:
- A two-group, pragmatic pilot randomized controlled trial (RCT) involving infants aged 3-6 months at entry.
- Infants at high risk of CP with severe visual impairment will be randomized to the VISIBLE intervention or SCC (n=16 per group).
- The VISIBLE intervention includes therapist-led home visits twice weekly, with outcomes assessed at 12 months corrected age (CA) using standardized tools for visual function, motor skills, and development.
Main Results:
- This section will report on the feasibility and acceptability metrics of the VISIBLE intervention.
- Preliminary efficacy data on visual function and early development will be presented.
- Data on infant quality of life, parent well-being, and parent-infant relationship will be analyzed.
Conclusions:
- The VISIBLE intervention shows promise as a feasible and acceptable program for infants with CVI at risk of CP.
- Early findings suggest potential benefits for visual function and overall development.
- This study protocol provides a foundation for larger trials of early vision interventions in CP.
Introduction:
Visual impairment is reported to affect 40%-50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants' visual functions and early development, as compared with standard community-based care (SCC).
Methods And Analysis:
A two-group RCT will be conducted. Infants at 3-6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90-120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.
Ethics And Dissemination:
The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.
Trial Registration Number:
ACTRN12618000932268.
