VIPPSTAR-G1 Digital Early Intervention for Visual Impairment

Summary

Visual impairment in infancy is associated with significant risks for neurodevelopmental impairment. Early intervention based on enriched visual and multisensory experiences may promote neuroplasticity and improve developmental outcomes, but implementation of intensive interventions in routine clinical practice remains challenging. The VIPPSTAR-G1 study evaluates a caregiver-mediated digital intervention delivered through a dedicated platform designed to support visual and neurodevelopmental functions in infants at risk of or with visual impairment, within a framework that promotes and strengthens the parent-child/caregiver-child relationship.

This multicenter, multinational, single-blind randomized controlled trial will enroll 102 newborns at risk of visual impairment and an additional exploratory pilot subgroup of 48 infants and toddlers with established visual impairment. Participants will be randomized to receive either the VIPPSTAR digital intervention plus standard care or standard care alone. Outcomes include visual acuity, smooth pursuit, additional neuro-ophthalmological functions, neurodevelopmental measures, adaptive functioning, language development, parental stress, quality of life, and feasibility of the digital intervention.

Conditions

• Visual Impairment
• Cerebral Visual Impairment
• Neurodevelopmental Disorders
• Prematurity

Interventions

OTHER

Standard Clinical Care

Routine clinical care provided according to local healthcare protocols, including follow-up visits and additional evaluations if clinically indicated.Standard intervention protocols according to local healthcare services are allowed.

BEHAVIORAL

VIPPSTAR Digital Early Intervention

A caregiver-mediated digital intervention aimed at promoting visual and neurodevelopmental outcomes in infants at risk of or with visual impairment, within a framework that promotes and strengthens the parent-child/caregiver-child relationship. The intervention includes individualized activities integrated into daily family routines and supported through remote supervision and e-learning content.

Sponsors & Collaborators

• ASST Spedali Civili of Brescia, Brescia, Italy

  collaborator UNKNOWN

• Department of Development and Regeneration, KU Leuven, Leuven, Belgium

  collaborator UNKNOWN

• Centrul Republican de Reabilitare pentru Copii, Moldova

  collaborator UNKNOWN

• Vestibular and oculomotor laboratory, Department of Neuroscience, Erasmus MC, Rotterdam, The Netherlands

  collaborator UNKNOWN

• National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy

  collaborator UNKNOWN

• LIGHT Center, Brescia, Italy

  collaborator UNKNOWN

• EODYNE SYSTEMS SL, Barcelona, Spain

  collaborator UNKNOWN

• Department of Psychology and Cognitive Science, University of Trento, Rovereto, Italy

  collaborator UNKNOWN

• Department of Brain and Behavioral Sciences University of Pavia, Pavia, Italy

  collaborator UNKNOWN

• Child Neurology and Psychiatry Unit IRCCS Mondino Foundation, Pavia, Italy

  collaborator UNKNOWN

• VIPPSTAR Consortium

  collaborator UNKNOWN

• Università degli Studi di Brescia

  lead OTHER

Principal Investigators

• Jessica Galli, Prof · Unit of Child Neurology and Psychiatry, ASST Spedali Civili of Brescia, Italy - Department of clinical and experimental sciences, University of Brescia, Brescia, Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

42 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2027-12-01

Completion

2028-06-30

Countries

• Belgium
• Italy
• Moldova

Study Locations