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ENROLLING BY INVITATION
NCT06310213
NA

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

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Months - 12 Months

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-01-24

Completion Date

2029-01-01

Last Updated

2025-10-08

Healthy Volunteers

No

Interventions

DEVICE

Non-Invasive Pressure Monitor

Modified smart soft contact lens and cap with reader coil

Locations (1)

Riley Hospital for Children

Indianapolis, Indiana, United States