VIPPSTAR-G1 Digital Early Intervention for Visual Impairment (VIPPSTAR-G1)
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jessica Galli, Professor
- 전화번호: 00390303995724
- 이메일: jessica.galli@unibs.it
연구 장소
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Chisinau, 몰도바, MD-2019
- Centrul Republican de Reabilitare pentru Copii
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연락하다:
- Ecaterina Gîncotă, Dr
- 전화번호: +373 686 84279
- 이메일: kbufteac@gmail.com
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부수사관:
- Amalia Dolinschii, Dr
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Leuven, 벨기에, 3000
- Katholieke Universiteit Leuven
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연락하다:
- Els Ortibus, Prof
- 전화번호: 0032 16 34 39 91
- 이메일: els.ortibus@uzleuven.be
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부수사관:
- Lauren Billestraet, Dr
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BS
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Brescia, BS, 이탈리아, 25123
- ASST Spedali Civili di Brescia
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연락하다:
- Serena Micheletti, Dr
- 전화번호: 00390303995724
- 이메일: serena.micheletti@unibs.it
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연락하다:
- Lucrezia Maria Visconti, Dr
- 전화번호: 00390303995724
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부수사관:
- Nicole D'Adda, Dr
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부수사관:
- Anna Alessandrini, Dr
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부수사관:
- Laura Dusi, Dr
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부수사관:
- Elisa Maria Fazzi, Prof
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Brescia, BS, 이탈리아, 25123
- University of Brescia
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부수사관:
- Laura Dusi, Dr
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연락하다:
- Jessica Galli, Prof
- 전화번호: 00390303995724
- 이메일: jessica.galli@unibs.it
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연락하다:
- Erika Loi, Dr
- 이메일: erika.loi@unibs.it
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부수사관:
- Erika Loi, Dr
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부수사관:
- Lucrezia Maria Visconti, Dr
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부수사관:
- Stefano Calza, Prof
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부수사관:
- Elisa Fazzi, Prof
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부수사관:
- Melissa Marras, Dr
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Pavia, BS, 이탈리아
- Department of Brain and Behavioral Sciences University of Pavia - Child Neurology and Psychiatry Unit IRCCS Mondino Foundation
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연락하다:
- Simona Orcesi, Prof
- 전화번호: 0039 0382.380280
- 이메일: simona.orcesi@unipv.it
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부수사관:
- Sabrina Signorini, Dr
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부수사관:
- Cecilia Naboni, Dr
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부수사관:
- Antonella Luparia, Dr
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부수사관:
- Sonia Trussardi, Dr
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부수사관:
- Benedetta Brafa, Dr
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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.
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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.
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다른: Standard Care Arm
Participants receive standard clinical monitoring and care according to local clinical practice without access to the VIPPSTAR intervention platform.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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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)
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Smooth pursuit assessed on an ordinal scale (continuous, discontinuous, difficult to elicit)
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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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)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fixation Stability assessed on an ordinal scale (stable for more than 3s, unstable for less than 3 s, difficult to evoke, not elicited)
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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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)
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Fixation Accuracy - eye tracker-based measure
기간: Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Change in fixation accuracy using eye tracker
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Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Smooth pursuit velocity - eye tracker-based measure
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Change in smooth pursuit velocity
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Smooth pursuit accuracy - eye tracker-based measure
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Change in smooth pursuit accuracy
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Smooth pursuit number of anticipatory movements - eye tracker based measure
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Change in smooth pursuit number of anticipatory movements
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Saccadic eye movements
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in saccadic eye movements using a categorial classification: present, normometric with increased latency, dysmetric but with normal latency, dysmetric with increased latency, absent
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Contrast sensitivity
기간: Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Change in the ability to identify targets, expressed as percentage of contrast level
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Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Binocular visual field
기간: Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Change in the ability to locate targets presented in different areas of the binocular visual field using clinical examination
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Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Visual Response Latencies - eye-tracker based measure
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in visual response latency
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Visual Response Speed - eye-tracker based measure
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes on visual response speed
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Visual Response Accuracy - eye-tracker based measure
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes on visual response accuracy
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Developmental Quotient at Bayley Scales of Infant and Toddler Development - IV edition
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in cognitive, motor and language quotients at Bayley Scales of Infant and Toddler Development-IV
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Developmental Quotient at Reynell Zinkin Scales of visual deficits
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in Developmental Quotient and subquotients at Reynell Zinkin Scales for infants with visual impairment aged 12 months and older (corrected age)
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Adaptive Functioning
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in raw scores, total quotient and subquotients at Vineland Adaptive Behavior Scales-III (VABS-III)
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Language Development
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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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
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Everyday visual-related behaviour questionnaire (Preverbal Visual Assessment - PreViAs)
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in the total score and subscores at Preverbal Visual Assessment (PreViAs) questionnaire for infants aged 23 months and younger (corrected age)
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Every day visual-related behaviour (CVI Parental Questionnaire)
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in the total score and subscores at CVI Parental Questionnaire for infants aged 24 months and older
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Parental Stress
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in total score and subscores at Parenting Stress Index-4 (PSI-4)
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Quality of Life scores
기간: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Changes in total score and subscores at Pediatric Quality of Life Inventory (PedsQL)
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Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
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Digital platform usability
기간: Baseline (T0), post-intervention at 24 weeks (T1)
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Evaluation of intervention usability through System Usability Scale (SUS)
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Baseline (T0), post-intervention at 24 weeks (T1)
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Intervention acceptability
기간: Baseline (T0), post-intervention at 24 weeks (T1)
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Evaluation of intervention acceptability through Acceptability of Intervention Measure (AIM)
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Baseline (T0), post-intervention at 24 weeks (T1)
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Intervention Appropriateness
기간: Baseline (T0), post-intervention at 24 weeks (T1)
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Evaluation of intervention appropriateness through Interventio Appropriateness Measure (IAM)
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Baseline (T0), post-intervention at 24 weeks (T1)
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Intervention feasibility
기간: Baseline (T0), post-intervention at 24 weeks (T1)
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Evaluation of intervention feasibility through Feasibility of Intervention Measures (FIM)
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Baseline (T0), post-intervention at 24 weeks (T1)
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: 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
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- VIPPSTARG1 - NP 6758
- Horizon Europe Grant Agreement (기타 보조금/기금 번호: European Commission)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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