Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06310213

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Hydrocephalus in Infants

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Invasive Pressure Monitor

Device

Modified smart soft contact lens and cap with reader coil

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 15, 2024
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.