An observational study in Preterm Less Than 32wks With IVH, WMI/PVL and Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 31 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Brigham and Women's Hospital · Observational
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.
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.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's planned enrollment of 60 is below the median of 126 across 97 observational studies indexed under Vision Disorders.
Browse Vision Disorders studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parent(s) or legal guardian(s) willing and able to provide
Exclusion Criteria:
Neonates whose parent(s) or guardian(s) cannot commit to long-term follow-up
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Prospective Clinical and Neurodevelopmental Data Collection
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.
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.
Time frame: 24 months of age
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.
Time frame: 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.
Time frame: 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
Time frame: 24 months
Plan to share: No — No plan to share individual participant data
Started Jul 2025 (actual). Primary completion is estimated for Dec 2027, 29 months after the start.
Of 51 non-industry observational studies under Vision Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's planned 29 months is above that.
Counting every sponsor, half of 58 studies reached it within 23 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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