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

October 3, 2025 updated by: Jignesh Tailor, Indiana University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being monitored for hydrocephalus, or healthy controls

Exclusion Criteria:

  • Known hypersensitivity to materials used in the contact lens and/or adhesive
  • Open/closed wounds at/near the anterior fontanelle
  • Anterior fontanelle is closed
  • Other conditions deemed relevant by the medical team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aim 1 Control
Intervention at single time point not to interfere with standard of care procedures
Device: Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Experimental: Aim 1 Hydrocephalus
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
Device: Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Experimental: Aim 2 Hydrocephalus, Shunt surgery
Intervention pre- and post-operatively
Device: Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Experimental: Aim 3 Hydrocephalus, EVD ICP monitor
Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)
Device: Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Experimental: Aim 4 Hydrocephalus, Reservoir surgery
Intervention pre- and post- ventricular reservoir tap(s)
Device: Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)
Time Frame: Day 1, continuously measured for up to 4 hours
ICP readings from the device will be compared to standard of care assessments and measurements in healthy control patients and hydrocephalus patients
Day 1, continuously measured for up to 4 hours
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)
Time Frame: Continuously measured for up to 4 hours prior to shunt surgery and continuously measured for up to 4 hours after shunt surgery
ICP readings from the device will be compared to standard of care assessments and measurements in patients undergoing shunt insertion
Continuously measured for up to 4 hours prior to shunt surgery and continuously measured for up to 4 hours after shunt surgery
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure during hydrocephalus evaluation (Aim 3)
Time Frame: Continuously measured for up to 4 hours while EVD/ICP monitoring is in place
ICP readings from the device will be compared to standard of care assessments and measurements in patients with an EVD/ICP monitor
Continuously measured for up to 4 hours while EVD/ICP monitoring is in place
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)
Time Frame: Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping
ICP readings from the device will be compared to standard of care assessments and measurements in patients with a reservoir, pre- and post-tap
Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Jignesh Tailor, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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