Preterm Less Than 32wks With IVH, WMI/PVLCVINCT07275021
Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates
An observational study of Preterm Less Than 32wks With IVH, WMI/PVL and Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries. CVI is a brain-based visual disorder in which visual acuity or visual fields are reduced despite a normal eye examination or greater-than-expected visual impairment… Read more about this study
- Who is it for?
- Ages 31 to 42 weeks
- Conditions the study is for
- Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
- What is being tested?
- Prospective Clinical and Neurodevelopmental Data Collection
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: The study population includes preterm and term infants at high risk for cerebral visual impairment due to neurological injury diagnosed in the neonatal period. This includes: * Preterm infants born <32 weeks gestation with intraventricular hemorrhage or white matter injury * Late preterm (34-36 weeks) and term (37-42 weeks) infants with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia or diagnosed with perinatal stroke Eligible infants are enrolled during their initial hospitalization and followed longitudinally into early childhood to assess visual development, neurodevelopmental outcomes, and early signs of cerebral visual impairment. Parent(s) or legal guardian(s) must be willing and able to provide informed consent.
Who may be able to join
- Preterm infants born < 32 weeks gestational age with any of the following:
- Germinal matrix/intraventricular hemorrhage (IVH)
- White matter injury (WMI), including periventricular leukomalacia (PVL)
- Late preterm infants (born 34-36 weeks gestation) or term infants (born 37-42 weeks gestation) with:
- Neonatal encephalopathy treated with therapeutic hypothermia for suspected hypoxic-ischemic encephalopathy (HIE)
- Infants diagnosed with perinatal stroke
- Parent(s) or legal guardian(s) willing and able to provide informed consent
Who cannot join
- Neonates whose parent(s) or guardian(s) cannot commit to long-term follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed El-Dib contact
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital, and Boston Children's Hospital
Boston, Massachusetts, 02115
Mohamed El-Dib, MD,
Gena Heidry, MD
About this study
Official title: The Vision Study: Cerebral/ Cortical Visual Impairment (CVI)
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries. CVI is a brain-based visual disorder in which visual acuity or visual fields are reduced despite a normal eye examination or greater-than-expected visual impairment relative to ocular pathology. CVI is increasingly recognized in children with neurological conditions, yet it often remains undiagnosed until later childhood, delaying opportunities for early intervention.
Population-based studies suggest that CVI is more common than previously understood. Recent estimates indicate that over 180,000 individuals in the United States aged 0-22 years may have diagnosed or likely CVI, with only a minority formally identified. Children with CVI frequently have co-occurring neurological conditions, including cerebral palsy, epilepsy, developmental delays, or genetic disorders. Infants born preterm or with conditions such as hypoxic-ischemic encephalopathy (HIE), perinatal stroke, or white matter injury are at particularly high risk. Prospective research also shows that a substantial proportion of infants born very preterm exhibit behavioral features of CVI later in childhood.
Read more
Despite improvements in neonatal neurocritical care, early detection of CVI remains challenging. Current clinical practice focuses on managing conditions such as HIE, perinatal stroke, periventricular leukomalacia, and other brain injuries, but there is limited research evaluating structured early identification pathways for CVI in infancy. Diagnostic tools such as brain MRI and Visual Evoked Potentials (VEP) have shown potential for identifying brain-based visual dysfunction, but their integration into early predictive models for CVI has not been fully explored.
This study addresses a critical gap in pediatric care by prospectively evaluating high-risk neonates using clinical, neuroimaging, neurophysiologic, and standardized developmental assessments through 24 months of age. Early identification of CVI may support timely referral for visual rehabilitation and developmental services, potentially improving long-term functional outcomes. Developing a predictive model for early CVI detection will contribute to improved clinical pathways, enhance early diagnosis, and reduce the long-term educational and social burden associated with undetected CVI. Ultimately, this research aims to improve outcomes and quality of life for infants at risk for brain-based visual impairment.
Read the detailed description
The study is a prospective observational study designed to follow preterm and term infants who are at high risk for Cerebral/ Cortical Visual Impairment (CVI). Preterm Infants born before 32 weeks gestational age with conditions such germinal matrix/intraventricular hemorrhage (IVH), white matter injury (WMI including periventricular leukomalacia (PVL), and late term and term infants with Hypoxic-Ischemic Encephalopathy (HIE) or prenatal Stroke will be enrolled during the neonatal intensive care unit (NICU) stay and monitored through a structured follow-up schedule. The study focuses on data collection using advanced diagnostic imaging and neurodevelopmental assessments without introducing randomization or experimental interventions.
- Conditions
- Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
- Being tested
- Prospective Clinical and Neurodevelopmental Data Collection
- Keywords
- Cerebral/ Cortical Visual Impairment, Vision Disorders, Cerebral/Cortical, Brain Injuries, Visual Disorders, Periventricular Leukomalacia, Hypoxic-Ischemic Encephalopathy, Hypoxia-Ischemia, Brain, White Matter Injury, Visual Evoked Potentials, Infant, Extremely Premature (for &amp;lt;32 weeks GA), Germinal Matrix Hemorrhage, Intraventricular Hemorrhage, Neonatal Encephalopathy, Prenatal Stroke
- Medical subject headings
- Vision Disorders, Brain Injuries, Leukomalacia, Periventricular, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Clinical and Neurodevelopmental Data CollectionOther
Participants undergo standardized collection of clinical, neuroimaging, neurophysiologic, visual assessment and neurodevelopmental data as part of this prospective observational study. Data include information obtained from clinical care and scheduled follow-up assessments through 24 months of age. No interventions are assigned.
| Study group | Role | What they receive |
|---|---|---|
| Preterm/Term High-Risk Infants | Infants at high risk for Cerebral/Cortical Visual Impairment (CVI), including preterm infants with IVH or white matter injury, term or late preterm infants with hypoxic-ischemic encephalopathy (HIE), and infants with perinatal stroke. Participants are followed prospectively and undergo standardized clinical, neuroimaging, neurophysiologic, and developmental assessments through 24 months of age. Receives: Other: Prospective Clinical and Neurodevelopmental Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Cerebral Visual Impairment (CVI) at 24 Months
Diagnosis of Cerebral/Cortical Visual Impairment (CVI) based on standardized clinical visual assessment performed.
Outcome measure: Low, or high risk.
Measured: 24 months of age
Secondary outcomes (3)
Visual Function assessment
Visual function evaluated using the age-appropriate CVI and parent questionnaire administered at scheduled follow-up intervals (6, 12, and 24 months per protocol), with primary reporting at 24 months.
- Teller acuity Cards (testing distance: 38 cms, 55 cms 84 cms)
- Patti Pics or grating acuity (testing distance: 25 cms, 50 cms and 100 cms)
- Visual behavior scale (grade: 1, 2, or 3)
- Resolution Distance Visual acuity
Outcome measure: Low, or high risk.
Measured: 24 months
Visual Evoked Potential (VEP) Response
Assessment of cortical visual pathway response using VEP performed at 6 and 24 months per protocol, with primary reporting at 24 months. Outcome measure: low or high risk group.
Measured: 24 months
Neurodevelopmental Composite Score
Standardized neurodevelopmental testing obtained as part of 12-, 18-, and 24-month clinical follow-up (e.g., Bayley-IV). Primary reporting at 24 months
Outcome measure:
- Low-Risk: scores within or above age-expected norms
- High-Risk: scores ≥1 SD below the mean (Standard Score <85) indicating developmental delay
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start7 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm Less Than 32wks With IVH, WMI/PVLStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Principal investigator, Mohamed El-Dib, MD, Brigham and Women's Hospital
- Investigators
- Mohamed El-Dib, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275021
- Sponsor's protocol ID
- 2025P001413
- Acronym
- CVI
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Publications
Chang MY, Borchert MS. Advances in the evaluation and management of cortical/cerebral visual impairment in children. Surv Ophthalmol. 2020 Nov-Dec;65(6):708-724. doi: 10.1016/j.survophthal.2020.03.001. Epub 2020 Mar 19.
PubMed 32199940Pilling RF, Allen L, Bowman R, Ravenscroft J, Saunders KJ, Williams C. Clinical assessment, investigation, diagnosis and initial management of cerebral visual impairment: a consensus practice guide. Eye (Lond). 2023 Jul;37(10):1958-1965. doi: 10.1038/s41433-022-02261-6. Epub 2022 Oct 18.
PubMed 36258009Sakki HEA, Dale NJ, Sargent J, Perez-Roche T, Bowman R. Is there consensus in defining childhood cerebral visual impairment? A systematic review of terminology and definitions. Br J Ophthalmol. 2018 Apr;102(4):424-432. doi: 10.1136/bjophthalmol-2017-310694. Epub 2017 Nov 16.
PubMed 29146757
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vision Study: Cerebral/ Cortical Visual Impairment (CVI)
- ClinicalTrials.gov ID
- NCT07275021
- Acronym / sponsor ID
- CVI / 2025P001413
- Conditions
- Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
- Keywords
- Cerebral/ Cortical Visual Impairment, Vision Disorders, Cerebral/Cortical, Brain Injuries, Visual Disorders, Periventricular Leukomalacia, Hypoxic-Ischemic Encephalopathy, Hypoxia-Ischemia, Brain, White Matter Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries. CVI is a brain-based visual disorder in which visual acuity or visual fields are reduced despite a normal eye examination or greater-than-expected visual impairment relative to ocular pathology. CVI is increasingly recognized in children with neurological conditions, yet it often remains undiagnosed until later childhood, delaying opportunities for early intervention.
Population-based studies suggest that CVI is more common than previously understood. Recent estimates indicate that over 180,000 individuals in the United States aged 0-22 years may have diagnosed or likely CVI, with only a minority formally identified. Children with CVI frequently have co-occurring neurological conditions, including cerebral palsy, epilepsy, developmental delays, or genetic disorders. Infants born preterm or with conditions such as hypoxic-ischemic encephalopathy (HIE), perinatal stroke, or white matter injury are at particularly high risk. Prospective research also shows that a substantial proportion of infants born very preterm exhibit behavioral features of CVI later in childhood.
Despite improvements in neonatal neurocritical care, early detection of CVI remains challenging. Current clinical practice focuses on managing conditions such as HIE, perinatal stroke, periventricular leukomalacia, and other brain injuries, but there is limited research evaluating structured early identification pathways for CVI in infancy. Diagnostic tools such as brain MRI and Visual Evoked Potentials (VEP) have shown potential for identifying brain-based visual dysfunction, but their integration into early predictive models for CVI has not been fully explored.
This study addresses a critical gap in pediatric care by prospectively evaluating high-risk neonates using clinical, neuroimaging, neurophysiologic, and standardized developmental assessments through 24 months of age. Early identification of CVI may support timely referral for visual rehabilitation and developmental services, potentially improving long-term functional outcomes. Developing a predictive model for early CVI detection will contribute to improved clinical pathways, enhance early diagnosis, and reduce the long-term educational and social burden associated with undetected CVI. Ultimately, this research aims to improve outcomes and quality of life for infants at risk for brain-based visual impairment.
Detailed description
The study is a prospective observational study designed to follow preterm and term infants who are at high risk for Cerebral/ Cortical Visual Impairment (CVI). Preterm Infants born before 32 weeks gestational age with conditions such germinal matrix/intraventricular hemorrhage (IVH), white matter injury (WMI including periventricular leukomalacia (PVL), and late term and term infants with Hypoxic-Ischemic Encephalopathy (HIE) or prenatal Stroke will be enrolled during the neonatal intensive care unit (NICU) stay and monitored through a structured follow-up schedule. The study focuses on data collection using advanced diagnostic imaging and neurodevelopmental assessments without introducing randomization or experimental interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm/Term High-Risk Infants | – | Other: Prospective Clinical and Neurodevelopmental Data CollectionInfants at high risk for Cerebral/Cortical Visual Impairment (CVI), including preterm infants with IVH or white matter injury, term or late preterm infants with hypoxic-ischemic encephalopathy (HIE), and infants with perinatal stroke. Participants are followed prospectively and undergo standardized clinical, neuroimaging, neurophysiologic, and developmental assessments through 24 months of age. |
Who may qualify
- Ages
- 31 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population includes preterm and term infants at high risk for cerebral visual impairment due to neurological injury diagnosed in the neonatal period. This includes: * Preterm infants born <32 weeks gestation with intraventricular hemorrhage or white matter injury * Late preterm (34-36 weeks) and term (37-42 weeks) infants with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia or diagnosed with perinatal stroke Eligible infants are enrolled during their initial hospitalization and followed longitudinally into early childhood to assess visual development, neurodevelopmental outcomes, and early signs of cerebral visual impairment. Parent(s) or legal guardian(s) must be willing and able to provide informed consent.
Key inclusion criteria (7 listed)
- Preterm infants born < 32 weeks gestational age with any of the following:
- Germinal matrix/intraventricular hemorrhage (IVH)
- White matter injury (WMI), including periventricular leukomalacia (PVL)
- Late preterm infants (born 34-36 weeks gestation) or term infants (born 37-42 weeks gestation) with:
- Neonatal encephalopathy treated with therapeutic hypothermia for suspected hypoxic-ischemic encephalopathy (HIE)
Key exclusion criteria (1 listed)
- Neonates whose parent(s) or guardian(s) cannot commit to long-term follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Clinical and Neurodevelopmental Data CollectionParticipants undergo standardized collection of clinical, neuroimaging, neurophysiologic, visual assessment and neurodevelopmental data as part of this prospective observational study. Data include information obtained from clinical care and scheduled follow-up assessments through 24 months of age. No interventions are assigned. | Other | Preterm/Term High-Risk Infants |
Primary outcome
Presence of Cerebral Visual Impairment (CVI) at 24 Months
Time frame: 24 months of age
Diagnosis of Cerebral/Cortical Visual Impairment (CVI) based on standardized clinical visual assessment performed. Outcome measure: Low, or high risk.
3 secondary outcomes
Visual Function assessment
Time frame: 24 months
Visual Evoked Potential (VEP) Response
Time frame: 24 months
Neurodevelopmental Composite Score
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Background: PubMed 32199940Chang MY, Borchert MS. Advances in the evaluation and management of cortical/cerebral visual impairment in children. Surv Ophthalmol. 2020 Nov-Dec;65(6):708-724. doi: 10.1016/j.survophthal.2020.03.001. Epub 2020 Mar 19.
- Background: PubMed 36258009Pilling RF, Allen L, Bowman R, Ravenscroft J, Saunders KJ, Williams C. Clinical assessment, investigation, diagnosis and initial management of cerebral visual impairment: a consensus practice guide. Eye (Lond). 2023 Jul;37(10):1958-1965. doi: 10.1038/s41433-022-02261-6. Epub 2022 Oct 18.
- Background: PubMed 29146757Sakki HEA, Dale NJ, Sargent J, Perez-Roche T, Bowman R. Is there consensus in defining childhood cerebral visual impairment? A systematic review of terminology and definitions. Br J Ophthalmol. 2018 Apr;102(4):424-432. doi: 10.1136/bjophthalmol-2017-310694. Epub 2017 Nov 16.
- Individual participant dataSharing planned: No. No plan to share individual participant data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed El-Dib contact
Mohamed El-Dib, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Less Than 32wks With IVH, WMI/PVL and Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed El-Dib, MD (+15712016409, mel-dib@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Cerebral Visual Impairment (CVI) at 24 Months (time frame: 24 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07275021, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.