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NCT06310213

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

Enrolling by Invitation
NAAges 0–12InterventionalScreening
Indiana University
~25 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:Non-Invasive Pressure Monitor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)
Measured over Day 1, continuously measured for up to 4 hours
+3 more outcomes measured

Conditions

Hydrocephalus in Infants

Explore related trials

Hydrocephalus

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Jignesh Tailor · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Being monitored for hydrocephalus, or healthy controls

Exclusion

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

What this trial measures

  • 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 4 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 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

  • Efficacy of modified smart soft contact lens evaluation of external intracranial pressure during hydrocephalus evaluation (Aim 3)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

  • Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)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