Hydrocephalus in Infants
Conditions
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.
Interventions
DEVICENon-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed