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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and statisticians will remain blinded to treatment allocation. Caregivers and intervention providers cannot be blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 1 Day 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols
时间窗: 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.
Smooth pursuit assessed on an ordinal scale (continuous, discontinuous, difficult to elicit)
时间窗: 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.
次要结局
- Visual Response Accuracy - eye-tracker based measure(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- 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))
- Saccadic eye movements(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Contrast sensitivity(Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Binocular visual field(Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Visual Response Latencies - eye-tracker based measure(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Visual Response Speed - eye-tracker based measure(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(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Developmental Quotient at Reynell Zinkin Scales of visual deficits(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Adaptive Functioning(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Language Development(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Everyday visual-related behaviour questionnaire (Preverbal Visual Assessment - PreViAs)(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Every day visual-related behaviour (CVI Parental Questionnaire)(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Parental Stress(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Quality of Life scores(Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2))
- Digital platform usability(Baseline (T0), post-intervention at 24 weeks (T1))
- Intervention acceptability(Baseline (T0), post-intervention at 24 weeks (T1))
- Intervention Appropriateness(Baseline (T0), post-intervention at 24 weeks (T1))
- Intervention feasibility(Baseline (T0), post-intervention at 24 weeks (T1))
研究者
Jessica Galli
Principal Investigator
Università degli Studi di Brescia