Clinical trial NCT06310213: Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
Official title: Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hydrocephalus in Infants
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)
timeFrame: Day 1, continuously measured for up to 24 hours
measure: Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)
timeFrame: Continuously measured for up to 24 hours prior to shunt surgery and continuously measured for up to 24 hours after shunt surgery
measure: Efficacy of modified smart soft contact lens evaluation of external intracranial pressure during hydrocephalus evaluation (Aim 3)
timeFrame: Continuously measured for up to 24 hours while EVD/ICP monitoring is in place
measure: Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)
timeFrame: Continuously measured for up to 24 hours prior to reservoir tapping and continuously measured for up to 24 hours after reservoir tapping
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Jignesh Tailor
role: PRINCIPAL_INVESTIGATOR
References: