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

N/AEnrolling By InvitationNCT06310213

Indiana University25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Hydrocephalus in Infants

Interventions

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 12 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping