Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are:
* Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without
* Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable.
Eligibility Criteria
This trial is for newborns and infants at risk of hydrocephalus, a condition where fluid builds up in the brain. They must be undergoing standard care for hydrocephalus to participate. The study excludes those who do not meet the specific criteria set by researchers.Inclusion Criteria
Healthy controls
Being monitored for hydrocephalus
Exclusion Criteria
Other conditions deemed relevant by the medical team
Known hypersensitivity to materials used in the contact lens and/or adhesive
I have wounds near the soft spot on the top of a baby's head.
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Participant Groups
Researchers are testing a new non-invasive pressure monitor using a smart soft contact lens to track changes in brain pressure in babies with and without hydrocephalus, before and after surgery or other treatments.
5Treatment groups
Experimental Treatment
Active Control
Group I: Aim 4 Hydrocephalus, Reservoir surgeryExperimental Treatment1 Intervention
Intervention pre- and post- ventricular reservoir tap(s)
Group II: Aim 3 Hydrocephalus, EVD ICP monitorExperimental Treatment1 Intervention
Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)
Group III: Aim 2 Hydrocephalus, Shunt surgeryExperimental Treatment1 Intervention
Intervention pre- and post-operatively
Group IV: Aim 1 HydrocephalusExperimental Treatment1 Intervention
Intervention at single time point during standard of care hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference), unless further assigned to supplemental arm following standard of care surgical procedure
Group V: Aim 1 ControlActive Control1 Intervention
Intervention at single time point not to interfere with standard of care procedures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Riley Hospital for ChildrenIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor