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Observational Study for Cerebral/Cortical Visual Impairment in Neonates

This study is looking at Cerebral/Cortical Visual Impairment (CVI), a brain-based vision problem, in newborns. It's an observational study, meaning researchers will collect information without giving any new treatments. They want to understand how CVI develops in babies who are at high risk, such as those born very early (before 32 weeks) with brain bleeds (IVH) or white matter injury (WMI/PVL), or full-term babies who had a lack of oxygen at birth (Neonatal Encephalopathy treated with Hypothermia for HIE). The goal is to find better ways to screen for and identify CVI early. Researchers will collect clinical, brain imaging, and vision information, and check on the babies' development up to 24 months of age. The study aims to see if CVI is present at 24 months of age.

Study design
This is an observational study that will follow 60 preterm and term infants. It does not involve randomization or experimental interventions.
What's involved
Participants will have clinical, neuroimaging, neurophysiologic, visual assessment, and neurodevelopmental data collected. This data will be gathered from their clinical care and scheduled follow-up appointments through 24 months of age.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through 24 months of age to assess for the presence of Cerebral Visual Impairment (CVI).

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NCT07275021

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

Recruiting
Not specifiedAges 31–42Observational
Brigham and Women's Hospital
~60 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:Prospective Clinical and Neurodevelopmental Data Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of Cerebral Visual Impairment (CVI) at 24 Months
Measured over 24 months of age

Conditions

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

Explore related trials

Cerebral Visual ImpairmentHypoxic Ischemic EncephalopathyIntraventricular Brain HemorrhageNeonatal EncephalopathyPerinatal StrokePeriventricular Leukomalacia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Mohamed El-Dib, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Mohamed El-Dib, MD
[email protected]
+15712016409
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Presence of Cerebral Visual Impairment (CVI) at 24 Months24 months of age

    Diagnosis of Cerebral/Cortical Visual Impairment (CVI) based on standardized clinical visual assessment performed. Outcome measure: Low, or high risk.