Recruiting

CVI Detection

Sponsor:

Brigham and Women's Hospital

Code:

NCT07275021

Conditions

Preterm Less Than 32wks With IVH, WMI/PVL

Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Prospective Clinical and Neurodevelopmental Data Collection

Study Details

Brief 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 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.

Conditions

Preterm Less Than 32wks With IVH, WMI/PVL

Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE

Study ID

NCT07275021

Start date

Jul 7, 2025

Status verified date

Aug, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

Neonates whose parent(s) or guardian(s) cannot commit to long-term follow-up

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital, and Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Gena Heidry, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Dec 10, 2025

Last verified

Aug, 2025

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;amp;lt;32 weeks GA)
  • Germinal Matrix Hemorrhage
  • Intraventricular Hemorrhage
  • Neonatal Encephalopathy
  • Prenatal Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-12-10.