NCT06310213

Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 0 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hydrocephalus in Infants

Interventions

Type	Name	Description
DEVICE	Non-Invasive Pressure Monitor	Modified smart soft contact lens and cap with reader coil

Timeline

• Start date: 2025-01-24
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2024-03-15
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study