VIPPSTAR-G1 Digital Early Intervention for Visual Impairment

NCT07717671 | Not Yet Recruiting

• 2 other identifiers: VIPPSTARG1 - NP 6758Horizon Europe Grant Agreement
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 5

Brief 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

Keywords

visual impairment; early intervention; digital health; prematurity

Outcome Measures

Primary Outcomes (2)

• Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols

  Assessment of improvement in visual acuity from baseline following the intervention. Primary efficacy analyses will be conducted in Study Sample 1 only. Data from Study Sample 2 will be analyzed descriptively and exploratorily.

  Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

• Smooth pursuit assessed on an ordinal scale (continuous, discontinuous, difficult to elicit)

  Assessment of changes in smooth pursuit eye movements assessed using a clinical evaluation on an ordinal scale (continuous, discontinuous, difficult to elicit). Primary efficacy analyses will be conducted in Study Sample 1 only. Data from Study Sample 2 will be analyzed descriptively and exploratorily.

  Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

Secondary Outcomes (23)

• Fixation Stability assessed on an ordinal scale (stable for more than 3s, unstable for less than 3 s, difficult to evoke, not elicited)

  Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

• Fixation Accuracy - eye tracker-based measure

  Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

• Smooth pursuit velocity - eye tracker-based measure

  Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

• Smooth pursuit accuracy - eye tracker-based measure

  Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

• Smooth pursuit number of anticipatory movements - eye tracker based measure

  Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

Study Arms (2)

Intervention arm

EXPERIMENTAL

Participants receive a caregiver-mediated, home-based digital intervention delivered through the VIPPSTAR platform, parallel to standard clinical care, within a framework that promotes and strengthens the parent-child/caregiver-child relationship. The intervention includes personalized developmental activities, audiovisual materials, weekly online supervision, and continuous communication with clinicians. It includes participants enrolled in both the main RCT cohort and the exploratory pilot cohort.

Behavioral: VIPPSTAR Digital Early Intervention

Standard Care Arm

OTHER

Participants receive standard clinical monitoring and care according to local clinical practice without access to the VIPPSTAR intervention platform.

Other: Standard Clinical Care

Interventions

VIPPSTAR Digital Early Intervention BEHAVIORAL

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.

Intervention arm

Standard Clinical Care OTHER

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.

Standard Care Arm

Eligibility Criteria

• Age: 1 Day - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≤32 weeks OR full-term/newborns\>32 weeks of age with neonatal distress (Apgar ≤5 at 10 minutes)
• NAVEG score ≥3
• At least one neurological or neuroimaging abnormality:
• abnormal signs at ATNAT neurological examination OR Abnormal cranial ultrasound findings OR Abnormal MRI findings

You may not qualify if:

• Epileptic encephalopathy
• Parents unable to understand local language
• Age ≤42 months
• Diagnosis of peripheral or cerebral visual impairment
• Age \>42 months
• Refractory epilepsy or epileptic encephalopathy
• Participation in another interventional study within previous 12 months
• Parents unable to understand local language

Sponsors & Collaborators

• Università degli Studi di Brescia: lead
• ASST Spedali Civili of Brescia, Brescia, Italy: collaborator
• Department of Development and Regeneration, KU Leuven, Leuven, Belgium: collaborator
• Centrul Republican de Reabilitare pentru Copii, Moldova: collaborator
• Vestibular and oculomotor laboratory, Department of Neuroscience, Erasmus MC, Rotterdam, The Netherlands: collaborator
• National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy: collaborator
• LIGHT Center, Brescia, Italy: collaborator
• EODYNE SYSTEMS SL, Barcelona, Spain: collaborator
• Department of Psychology and Cognitive Science, University of Trento, Rovereto, Italy: collaborator
• Department of Brain and Behavioral Sciences University of Pavia, Pavia, Italy: collaborator
• Child Neurology and Psychiatry Unit IRCCS Mondino Foundation, Pavia, Italy: collaborator
• VIPPSTAR Consortium: collaborator

Study Sites (5)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

ASST Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

University of Brescia

Brescia, BS, 25123, Italy

Location

Department of Brain and Behavioral Sciences University of Pavia - Child Neurology and Psychiatry Unit IRCCS Mondino Foundation

Pavia, BS, Italy

Location

Centrul Republican de Reabilitare pentru Copii

Chisinau, MD-2019, Moldova

Location

Related Links

• Website of the VIPPSTAR project

MeSH Terms

Conditions

Vision Disorders; Blindness, Cortical; Neurodevelopmental Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blindness; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Galli, Professor

CONTACT

00390303995724; jessica.galli@unibs.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and statisticians will remain blinded to treatment allocation. Caregivers and intervention providers cannot be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This protocol includes: * one randomized controlled trial (Study Sample 1) * one exploratory pilot study (Study Sample 2)

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 21, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: De-identified individual participant data will become available after the end of the trial and will remain available for at least 4 years (art. 16 GA), subject to the abscence of objection from the Vippstar's Granting Authority, to the applicable measures determined within the consortium agreement and DMP and to the applicable data protection regulations.
• Access Criteria: Access to data will be provided to qualified applicants upon reasonable and lawful request, following approval by the Sponsor, the abscence of objection from the Vippstar's Granting Authority and execution of applicable data sharing and data processing agreements in compliance with GDPR and institutional policies. After one year from the end of the trial, access may also be reached according to the Horizon Results Platform's terms and provisions.

Locations

MO (1); BE (1); IT (3)