BMJ open · 2026
Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) - protocol of a feasibility pilot randomised controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Guzzetta Andrea, Bancale Ada, Bedoshvili Anna, Bosanquet Margot, Chorna Olena, Corsi Giulia, Del Secco Sabrina, Elliott Catherine, Fiori Simona, Fripp Jurgen, Gole Glen A, Gordon Anya, Harpster Karen, Hunt Rod W, Leishman Shaneen, Mori Rosalie, Morgan Catherine, Novak Iona, Pagnozzi Alex Michael, Pannek Kerstin, Philip Swetha Sara, Rice Melissa, Salt Alison, Shannon Bernadette, Schwartz Terry, Tatishvili Nana Nino, Tatishvili Sofia, Boyd Roslyn N
Аннотация
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.
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.