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VIPPSTAR-G1 Digital Early Intervention for Visual Impairment (VIPPSTAR-G1)

2026年7月16日 更新者:Jessica Galli、Università degli Studi di Brescia

VIPPSTAR-G1: A Multicenter Randomized Controlled Trial Evaluating a Caregiver-mediated Digital Intervention to Promote Visual Function and Neurodevelopment in Infants at Risk of/With Visual Impairment

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.

研究概览

详细说明

The VIPPSTAR-G1 study is a multicenter, multinational clinical trial evaluating a caregiver-mediated digital early intervention designed to promote visual function and neurodevelopment in infants at risk of or with visual impairment (VI), within a framework that promotes and strengthens the parent-child/caregiver-child relationship. The study is conducted within the framework of the VIPPSTAR Horizon Europe project and integrates telemedicine, digital health technologies, and individualized developmental support into routine clinical care.

Visual function plays a fundamental role in early neurodevelopment. Vision represents the primary means through which infants explore and interact with the environment, while environmental experiences simultaneously shape the maturation and plasticity of visual pathways and broader neurodevelopmental networks. Visual impairment in infancy is therefore associated not only with altered visual functioning but also with increased risk for motor, cognitive, communicative, adaptive, and socio-emotional developmental difficulties.

Visual impairment includes peripheral visual impairment (PVI), caused by ocular or anterior visual pathway disorders, and cerebral visual impairment (CVI), resulting from damage or dysfunction affecting post-geniculate visual pathways and visual cortical networks. These disorders often co-occur. CVI has become one of the leading causes of childhood visual disability in industrialized countries, particularly among infants born preterm or with neonatal neurological complications.

Although early individualized intervention and visually enriched experiences are considered essential to support neuroplasticity and developmental outcomes, implementation of intensive family-centered intervention programs in real-world healthcare systems remains challenging because of limited accessibility, geographic barriers, shortage of specialized services, and socioeconomic constraints affecting families. Digital and telemedicine-based interventions may help overcome these limitations by enabling remote delivery of evidence-based developmental support integrated into everyday family routines.

The VIPPSTAR-G1 protocol evaluates a caregiver-mediated home-based intervention delivered through a dedicated digital platform. The platform provides individualized developmental activities, audiovisual guidance materials, e-learning resources, remote supervision, and continuous communication with clinicians. The intervention is designed to promote naturalistic developmental learning and parent-child interaction within the child's daily environment.

The protocol includes two distinct study populations conducted under a shared methodological framework:

Study Sample 1 - Randomized Controlled Trial Cohort It constitutes the definitive randomized controlled trial (RCT) component of the protocol. This cohort includes 102 newborns at risk of visual impairment recruited from Neonatal Intensive Care Units (NICUs), nurseries, and neuropsychiatry outpatient clinics across participating sites in Italy, Belgium, and Moldova.

Eligible infants are randomized in a 1:1 ratio to: the VIPPSTAR caregiver-mediated digital intervention plus standard care, or standard clinical care alone. Randomization is stratified by recruitment site and biological sex using computer-generated permuted blocks implemented through the REDCap randomization module.

The primary objective of the RCT cohort is to evaluate the efficacy of the intervention in improving: 1)visual acuity, and 2)smooth pursuit eye movements.

Secondary objectives include assessment of: visual processing speed and ocular motor functioning through gaze metrics and qualitative assessments, developmental quotient, adaptive behavior, language development, everyday visual-related behavior, parental stress, quality of life, feasibility, acceptability and usability of the intervention. Primary confirmatory efficacy analyses will be conducted exclusively in Study Sample 1.

Study Sample 2 - Exploratory Pilot Cohort It is an additional exploratory pilot subgroup including 48 infants and toddlers up to 42 months of age with established peripheral or cerebral visual impairment or both.

The objective of this cohort is to evaluate: feasibility, acceptability, usability, adherence, implementation procedures, and preliminary clinical effects of the intervention in a broader clinical population beyond neonates at risk of visual impairment.

Participants in the pilot subgroup follow the same assessment and intervention framework and assessment schedule used in the main RCT cohort. However, this exploratory cohort is not powered for confirmatory efficacy analyses. Data derived from this subgroup will primarily be analyzed descriptively and used to inform future refinement and scalability of the intervention model.

Intervention Description The intervention is a non-pharmacological, non-invasive, caregiver-mediated developmental program delivered remotely through the VIPPSTAR digital platform over a 6-months period.

The platform includes: individualized developmental activities, video demonstrations, audio instructions, e-learning educational materials, secure communication systems, weekly online supervision sessions with clinicians, monitoring tools for adherence and feasibility.

Activities are personalized according to each child's developmental profile, visual functioning, and clinical needs, and are integrated into everyday family routines such as play, caregiving interactions, and home activities.

Clinicians monitor intervention delivery through the digital platform and adapt activities over time according to child responses and caregiver feedback.

Participants allocated to the control group receive standard clinical care according to local institutional practice, including routine follow-up visits and access to clinical communication channels when needed.

Study Timeline and Assessments Participants undergo evaluations at: baseline before randomization (T0), post-intervention after 24 weeks (T1), 6-month follow-up after intervention completion (T2).

Assessments include: neuro-ophthalmological evaluation including ophthalmological assessment and basic visual functions/ocular motor function evaluation; visual processing speed/ eye-tracking based ocularmotor parameters, developmental testing including the assessment of developmental quotient, adaptive behavior assessment, language assessment, parental stress questionnaires, quality-of-life measures, feasibility, acceptability and usability measures.

Outcome assessors and statisticians remain blinded to treatment allocation whenever feasible.

Outcomes

The co-primary outcomes for the RCT cohort are:

Change improvement of visual acuity Change in smooth pursuit function

Secondary outcomes evaluate broader neurodevelopmental, neuro-ophthalmological parameters, adaptive behavior, parental stress, quality of life, and feasibility of the digital intervention.

Data Management and Data Sharing Study data are collected and managed through a centralized REDCap platform hosted at the University of Brescia. All data are pseudo-anonymized and handled in compliance with GDPR and applicable national regulations.

De-identified individual participant data (IPD) underlying published study results may be shared upon reasonable request after publication of the primary analyses. Statistical code, metadata, and data dictionaries may also be shared for academic, non-commercial research purposes.

In preparation for multicenter data exchange and digital platform implementation, the consortium is establishing the necessary Data Sharing Agreements, Data Processing Agreements, and software governance procedures among participating institutions and technology providers to ensure secure, compliant, and ethically governed handling of study data.

Ethical Considerations The study has received ethics approval from Comitato Etico Territoriale Lombardia 6 (Approval No. VIPPSTAR G1 - NP 6758; approved 4th June 2026). Written informed consent is obtained from parents or legal guardians before participation.

Given the non-invasive and caregiver-mediated nature of the intervention, the study is considered minimal risk. Safety monitoring procedures are implemented throughout the study period, including systematic monitoring of adverse events, participant burden, and intervention tolerability.

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • BS
      • Brescia、BS、意大利、25123
        • ASST Spedali Civili di Brescia
        • 接触:
        • 接触:
          • Lucrezia Maria Visconti, Dr
          • 电话号码:00390303995724
        • 副研究员:
          • Nicole D'Adda, Dr
        • 副研究员:
          • Anna Alessandrini, Dr
        • 副研究员:
          • Laura Dusi, Dr
        • 副研究员:
          • Elisa Maria Fazzi, Prof
      • Brescia、BS、意大利、25123
        • University of Brescia
        • 副研究员:
          • Laura Dusi, Dr
        • 接触:
        • 接触:
        • 副研究员:
          • Erika Loi, Dr
        • 副研究员:
          • Lucrezia Maria Visconti, Dr
        • 副研究员:
          • Stefano Calza, Prof
        • 副研究员:
          • Elisa Fazzi, Prof
        • 副研究员:
          • Melissa Marras, Dr
      • Pavia、BS、意大利
        • Department of Brain and Behavioral Sciences University of Pavia - Child Neurology and Psychiatry Unit IRCCS Mondino Foundation
        • 接触:
        • 副研究员:
          • Sabrina Signorini, Dr
        • 副研究员:
          • Cecilia Naboni, Dr
        • 副研究员:
          • Antonella Luparia, Dr
        • 副研究员:
          • Sonia Trussardi, Dr
        • 副研究员:
          • Benedetta Brafa, Dr
      • Chisinau、摩尔多瓦、MD-2019
        • Centrul Republican de Reabilitare pentru Copii
        • 接触:
        • 副研究员:
          • Amalia Dolinschii, Dr
      • Leuven、比利时、3000
        • Katholieke Universiteit Leuven
        • 接触:
        • 副研究员:
          • Lauren Billestraet, Dr

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment

  • 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:

    • 3 abnormal signs at ATNAT neurological examination OR Abnormal cranial ultrasound findings OR Abnormal MRI findings

Exclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment

  • Epileptic encephalopathy
  • Parents unable to understand local language

Inclusion Criteria: Study Sample 2 - Infants/Toddlers With Visual Impairment

  • Age ≤42 months
  • Diagnosis of peripheral or cerebral visual impairment
  • Moderate or severe visual impairment documented by standardized visual acuity testing Exclusion Criteria: Study Sample 2 - Infants/Toddlers With 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention arm
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.
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.
其他:Standard Care Arm
Participants receive standard clinical monitoring and care according to local clinical practice without access to the VIPPSTAR intervention platform.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

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

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)

次要结果测量

结果测量
措施说明
大体时间
Fixation Stability assessed on an ordinal scale (stable for more than 3s, unstable for less than 3 s, difficult to evoke, not elicited)
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Evaluation of changes in fixation stability using clinical examination (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
大体时间:Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in fixation accuracy using eye tracker
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Smooth pursuit velocity - eye tracker-based measure
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in smooth pursuit velocity
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Smooth pursuit accuracy - eye tracker-based measure
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in smooth pursuit accuracy
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Smooth pursuit number of anticipatory movements - eye tracker based measure
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in smooth pursuit number of anticipatory movements
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Saccadic eye movements
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in saccadic eye movements using a categorial classification: present, normometric with increased latency, dysmetric but with normal latency, dysmetric with increased latency, absent
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Contrast sensitivity
大体时间:Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in the ability to identify targets, expressed as percentage of contrast level
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Binocular visual field
大体时间:Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in the ability to locate targets presented in different areas of the binocular visual field using clinical examination
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Visual Response Latencies - eye-tracker based measure
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in visual response latency
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Visual Response Speed - eye-tracker based measure
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes on visual response speed
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Visual Response Accuracy - eye-tracker based measure
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes on visual response accuracy
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Developmental Quotient at Bayley Scales of Infant and Toddler Development - IV edition
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in cognitive, motor and language quotients at Bayley Scales of Infant and Toddler Development-IV
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Developmental Quotient at Reynell Zinkin Scales of visual deficits
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in Developmental Quotient and subquotients at Reynell Zinkin Scales for infants with visual impairment aged 12 months and older (corrected age)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Adaptive Functioning
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in raw scores, total quotient and subquotients at Vineland Adaptive Behavior Scales-III (VABS-III)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Language Development
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in the number of understood/spoken words and sentences, changes in the number of gestures as reported at MacArthur-Bates Communicative Development Inventories (MB-CDI) by parents
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Everyday visual-related behaviour questionnaire (Preverbal Visual Assessment - PreViAs)
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in the total score and subscores at Preverbal Visual Assessment (PreViAs) questionnaire for infants aged 23 months and younger (corrected age)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Every day visual-related behaviour (CVI Parental Questionnaire)
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in the total score and subscores at CVI Parental Questionnaire for infants aged 24 months and older
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Parental Stress
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in total score and subscores at Parenting Stress Index-4 (PSI-4)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Quality of Life scores
大体时间:Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in total score and subscores at Pediatric Quality of Life Inventory (PedsQL)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Digital platform usability
大体时间:Baseline (T0), post-intervention at 24 weeks (T1)
Evaluation of intervention usability through System Usability Scale (SUS)
Baseline (T0), post-intervention at 24 weeks (T1)
Intervention acceptability
大体时间:Baseline (T0), post-intervention at 24 weeks (T1)
Evaluation of intervention acceptability through Acceptability of Intervention Measure (AIM)
Baseline (T0), post-intervention at 24 weeks (T1)
Intervention Appropriateness
大体时间:Baseline (T0), post-intervention at 24 weeks (T1)
Evaluation of intervention appropriateness through Interventio Appropriateness Measure (IAM)
Baseline (T0), post-intervention at 24 weeks (T1)
Intervention feasibility
大体时间:Baseline (T0), post-intervention at 24 weeks (T1)
Evaluation of intervention feasibility through Feasibility of Intervention Measures (FIM)
Baseline (T0), post-intervention at 24 weeks (T1)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年6月30日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年7月16日

首次发布 (实际的)

2026年7月21日

研究记录更新

最后更新发布 (实际的)

2026年7月21日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual participant data (IPD) underlying the results reported in publications, including demographic, clinical, neurodevelopmental, neuro-ophthalmological, eye-tracking, and questionnaire-derived outcome data, will be made available upon reasonable request after publication of the primary study results.

Statistical analysis code may also be shared for academic, non-commercial research purposes.

All data sharing requests will be subject to approval by the Sponsor and compliance with applicable national and European data protection regulations, including GDPR requirements. No directly identifiable participant data will be shared.

In preparation for multicenter data exchange and digital platform use, the study consortium is establishing the necessary Data Sharing Agreements, Data Processing Agreements, and software governance procedures among participating institutions and technology providers to ensure secure, compliant, and ethically governed handling of study data.

IPD 共享时间框架

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.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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