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

16 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Belgia
      • Leuven, Belgia, 3000
        • Katholieke Universiteit Leuven
        • Kontakt:
        • Pod-śledczy:
          • Lauren Billestraet, Dr
  • Moldova
      • Chisinau, Moldova, MD-2019
        • Centrul Republican de Reabilitare pentru Copii
        • Kontakt:
        • Pod-śledczy:
          • Amalia Dolinschii, Dr
  • Włochy
    • BS
      • Brescia, BS, Włochy, 25123
        • ASST Spedali Civili di Brescia
        • Kontakt:
        • Kontakt:
          • Lucrezia Maria Visconti, Dr
          • Numer telefonu: 00390303995724
        • Pod-śledczy:
          • Nicole D'Adda, Dr
        • Pod-śledczy:
          • Anna Alessandrini, Dr
        • Pod-śledczy:
          • Laura Dusi, Dr
        • Pod-śledczy:
          • Elisa Maria Fazzi, Prof
      • Brescia, BS, Włochy, 25123
        • University of Brescia
        • Pod-śledczy:
          • Laura Dusi, Dr
        • Kontakt:
        • Kontakt:
        • Pod-śledczy:
          • Erika Loi, Dr
        • Pod-śledczy:
          • Lucrezia Maria Visconti, Dr
        • Pod-śledczy:
          • Stefano Calza, Prof
        • Pod-śledczy:
          • Elisa Fazzi, Prof
        • Pod-śledczy:
          • Melissa Marras, Dr
      • Pavia, BS, Włochy
        • Department of Brain and Behavioral Sciences University of Pavia - Child Neurology and Psychiatry Unit IRCCS Mondino Foundation
        • Kontakt:
        • Pod-śledczy:
          • Sabrina Signorini, Dr
        • Pod-śledczy:
          • Cecilia Naboni, Dr
        • Pod-śledczy:
          • Antonella Luparia, Dr
        • Pod-śledczy:
          • Sonia Trussardi, Dr
        • Pod-śledczy:
          • Benedetta Brafa, Dr

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Inny: Standard Care Arm
Participants receive standard clinical monitoring and care according to local clinical practice without access to the VIPPSTAR intervention platform.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Fixation Stability assessed on an ordinal scale (stable for more than 3s, unstable for less than 3 s, difficult to evoke, not elicited)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Università degli Studi di Brescia

Współpracownicy

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

Śledczy

  • Główny śledczy: 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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

30 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

23 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 lipca 2026

Pierwszy wysłany (Rzeczywisty)

21 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • VIPPSTARG1 - NP 6758
  • Horizon Europe Grant Agreement (Inny numer grantu/finansowania: European Commission)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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