Screening and predicting outcomes for brain-related vision problems in newborns
Official title: The Vision Study: Cerebral/ Cortical Visual Impairment (CVI)
Run by Brigham and Women's Hospital · NCT07275021 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 31 Weeks to 42 Weeks |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | July 7, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT07275021 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.