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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06310213
Status
Enrolling By Invitation

Conditions

  • Hydrocephalus in Infants

Eligibility Criteria

Sex
ALL
Age
0 Months - 12 Months
Healthy Volunteers
Not accepted

Interventions

  • Non-Invasive Pressure Monitor — DEVICE
    Modified smart soft contact lens and cap with reader coil

Study Details

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.

Key Dates

Start date
Jan 24, 2025
Status verified
Sep 2025
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

Arms

  • Active Comparator: Aim 1 Control
    Intervention at single time point not to interfere with standard of care procedures
  • Experimental: Aim 1 Hydrocephalus
    Intervention at single time point during standard of care hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference), unless further assigned to supplemental arm following standard of care surgical procedure
  • Experimental: Aim 2 Hydrocephalus, Shunt surgery
    Intervention pre- and post-operatively
  • Experimental: Aim 3 Hydrocephalus, EVD ICP monitor
    Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)
  • Experimental: Aim 4 Hydrocephalus, Reservoir surgery
    Intervention pre- and post- ventricular reservoir tap(s)

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Riley Hospital for ChildrenIndianapolisIndiana46202-

Find similar trials in Indianapolis, IN

By research site
Riley Hospital for Children· Indianapolis, IN

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