Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates

Conditions

• Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
• Preterm Less Than 32wks With IVH, WMI/PVL

Eligibility Criteria

Sex

ALL

Age

31 Weeks - 42 Weeks

Healthy Volunteers

Not accepted

Interventions

• Prospective Clinical and Neurodevelopmental Data Collection — OTHER
  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 Details

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.

Key Dates

Start date

Jul 7, 2025

Status verified

Aug 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

60 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Presence of Cerebral Visual Impairment (CVI) at 24 Months [ Time Frame: 24 months of age ]

Central Contacts

• Mohamed El-Dib, MD
  +15712016409
  [email protected]
• Mohamed El-Dib

Locations (1)

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