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

NCT06310213 | Enrolling By Invitation FDA Device

• 1 other identifier: 17368
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)

  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)

  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)

  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)

  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

Study Arms (5)

Aim 1 Control

ACTIVE COMPARATOR

Intervention at single time point not to interfere with standard of care procedures

Device: Non-Invasive Pressure Monitor

Aim 1 Hydrocephalus

EXPERIMENTAL

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

Aim 2 Hydrocephalus, Shunt surgery

EXPERIMENTAL

Intervention pre- and post-operatively

Device: Non-Invasive Pressure Monitor

Aim 3 Hydrocephalus, EVD ICP monitor

EXPERIMENTAL

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

Aim 4 Hydrocephalus, Reservoir surgery

EXPERIMENTAL

Intervention pre- and post- ventricular reservoir tap(s)

Device: Non-Invasive Pressure Monitor

Interventions

Non-Invasive Pressure Monitor DEVICE

Modified smart soft contact lens and cap with reader coil

Aim 1 Control; Aim 1 Hydrocephalus; Aim 2 Hydrocephalus, Shunt surgery; Aim 3 Hydrocephalus, EVD ICP monitor; Aim 4 Hydrocephalus, Reservoir surgery

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being monitored for hydrocephalus, or healthy controls

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Jignesh Tailor

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Model Details: Aim 1: Comparison of neonates and infants with hydrocephalus and without Aim 2: Using smart soft contact lens (SSCL) for pre- and post-operative measurements on neonates and/or infants managed operatively (shunt placement) Aim 3: Direct validation by comparing SSCL to external ventricular drain (EVD) intracranial pressure (ICP) monitoring Aim 4: Using SSCL for pre- and post- reservoir tap measurements on neonates and/or infants managed operatively (reservoir placement) Aim 1: 10 patients per arm, two arms Aim 2: 5-10 patients, one arm Aim 3: 5-10 patients, one arm Aim 4: 5-10 patients, one arm

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: January 24, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)