Screening and predicting outcomes for brain-related vision problems in newborns
The Vision Study: Cerebral/ Cortical Visual Impairment (CVI)
This project will see if advanced brain imaging and scheduled follow-up can identify and predict cerebral/cortical visual impairment (CVI) in newborns born very preterm or who had hypoxic-ischemic encephalopathy or perinatal stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 31 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07275021 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational effort that follows high-risk neonates enrolled during their NICU stay, including infants born before 32 weeks with IVH or white matter injury, late preterm/term infants treated with therapeutic hypothermia for HIE, and infants with perinatal stroke. The team will collect advanced neuroimaging and structured neurodevelopmental and vision assessments at set intervals without introducing experimental interventions. Data will be used to screen for early signs of CVI, characterize its features, and develop predictors of later visual outcome. The approach aims to improve early referral and management pathways for infants at risk of brain-based vision loss.
Who should consider this trial
Good fit: Ideal candidates are neonates treated at the enrolling hospitals who are born <32 weeks with IVH or white matter injury, late preterm/term infants treated with therapeutic hypothermia for suspected HIE, or infants diagnosed with perinatal stroke whose parents can provide consent.
Not a fit: Infants without these specific neonatal brain injuries or whose families cannot commit to long-term follow-up are unlikely to benefit from the study's screening and prediction efforts.
Why it matters
Potential benefit: If successful, the work could enable earlier diagnosis of CVI and more targeted early therapies that improve visual and developmental outcomes.
How similar studies have performed: Previous observational and imaging studies have identified markers and risk factors for CVI, but comprehensive prospective outcome prediction in high-risk neonatal cohorts is still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital, and Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Mohamed El-Dib, MD — Brigham and Women's Hospital
- Study coordinator: Mohamed El-Dib, MD
- Email: mel-dib@bwh.harvard.edu
- Phone: +15712016409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.