{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T12:26:24Z","timestamp":1793967984326,"version":"4.8.0"},"reference-count":61,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T00:00:00Z","timestamp":1776643200000},"content-version":"unspecified","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"European Union\u2019s Horizon 2020 Research and Innovation programme","award":["No. 848201"],"award-info":[{"award-number":["No. 848201"]}]},{"name":"Australian National Health and Medical Research Council Investigator Grant","award":["NHMRC, 1195602"],"award-info":[{"award-number":["NHMRC, 1195602"]}]},{"name":"QEDIN Network is funded by the Queensland Dept of Innovation Advance QLD program and the Merchant Charitable Foundation"},{"DOI":"10.13039\/100012256","name":"Research Foundation of Cerebral Palsy Alliance","doi-asserted-by":"crossref","award":["PG15717"],"award-info":[{"award-number":["PG15717"]}],"id":[{"id":"10.13039\/100012256","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Childrens Hospital Foundation (CHF) in Queensland"},{"DOI":"10.13039\/501100003196","name":"Italian Ministry of Health","doi-asserted-by":"crossref","award":["RC-2024-2025"],"award-info":[{"award-number":["RC-2024-2025"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,1,26]]},"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Visual impairment is reported to affect 40%\u201350% 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.<\/jats:p>\n                    <jats:p>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\u2019 visual functions and early development, as compared with standard community-based care (SCC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A two-group RCT will be conducted. Infants at 3\u20136 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\u2013120 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ACTRN12618000932268.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-114567","type":"journal-article","created":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T14:45:26Z","timestamp":1776696326000},"page":"e114567","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) \u2013 protocol of a feasibility pilot randomised controlled trial"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3868-0059","authenticated-orcid":false,"given":"Andrea","family":"Guzzetta","sequence":"first","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy"},{"name":"Department of Developmental Neuroscience, IRCCS Stella Maris, Pisa, 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