Early intervention for children at risk of visual processing dysfunctions from 1 year of age: a Randomized Controlled Trial protocol

• DOI: 10.21203/rs.2.12202/v2
• Publication Date: 2019-11-19T15:33:50Z
• Authors: Marlou Kooiker; Yoni van der Linden; Jenneke van Dijk; Ymie J van der Zee; Renate MC Swarte; Liesbeth S Smit; Sanny van der Ste...; Sjoukje E Loudon; Irwin KM Reiss; Kees Kuyper; Johan JM Pel; Johannes van der ...
• Keywords: Male; Medicine (General); Visual intervention; Time Factors; EMC MM-03-54-04-A; Vision Disorders; Cerebral visual impairment; EMC NIHES-02-67-01; Time-to-Treatment; Perceptual Disorders; Study Protocol; 03 medical and health sciences; R5-920; Child Development; Cognition; 0302 clinical medicine; Humans; Single-Blind Method; Visual attention; Netherlands; Randomized Controlled Trials as Topic; Eye tracking; Brain; Infant; 3. Good health; Treatment Outcome; Neurodevelopmental Disorders; Child, Preschool; Visual Perception; Premature Birth; Female; Visual habilitation; Neurological risk; Follow-Up Studies

Abstract Background An increasing amount of children suffer from brain damage-related visual processing dysfunctions (VPD). At present, there is a lack of evidence-based intervention methods that can be used early in development. We developed a visual intervention protocol suitable from 1 year of age. The protocol is structured, comprehensive and individually-adaptive and is paired with quantitative outcome assessments. Our aim is to investigate effectiveness of this first visual intervention program for young children with (a risk of) VPD. Methods We conduct a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (<30 weeks) of 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care: an ophthalmic and visual function assessment and a (newly developed) visual intervention program. This program consist of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to specific needs of the child).. Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA), or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual intervention will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention). Discussion Through this RCT we will establish the effectiveness of a new and early visual intervention program. Combining a general and supplement protocol enables both structured comparisons between participants and groups, and custom habilitation that is tailored to the children’s specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving an intervention. We expect results to be applicable to the overall population of children with (a risk of) VPD early in life.