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

Not Applicable

• Conditions: Hydrocephalus in Infants
• Interventions: Device: Non-Invasive Pressure Monitor

• Registration Number: NCT06310213
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-15
• Study Start: 2025-01-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2029-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Aim 1 Control	Non-Invasive Pressure Monitor	Intervention at single time point not to interfere with standard of care procedures
Aim 2 Hydrocephalus, Shunt surgery	Non-Invasive Pressure Monitor	Intervention pre- and post-operatively
Aim 4 Hydrocephalus, Reservoir surgery	Non-Invasive Pressure Monitor	Intervention pre- and post- ventricular reservoir tap(s)
Aim 1 Hydrocephalus	Non-Invasive Pressure Monitor	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
Aim 3 Hydrocephalus, EVD ICP monitor	Non-Invasive Pressure Monitor	Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)

Primary Outcome Measures

Name	Time	Method
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure during hydrocephalus evaluation (Aim 3)	Continuously measured for up to 24 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
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)	Day 1, continuously measured for up to 24 hours	ICP readings from the device will be compared to standard of care assessments and measurements in healthy control patients and hydrocephalus patients
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)	Continuously measured for up to 24 hours prior to shunt surgery and continuously measured for up to 24 hours after shunt surgery	ICP readings from the device will be compared to standard of care assessments and measurements in patients undergoing shunt insertion
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)	Continuously measured for up to 24 hours prior to reservoir tapping and continuously measured for up to 24 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

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States