Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Invasive Pressure Monitor.
- Who it may be relevant to
- Registry conditions: Hydrocephalus in Infants. Basic parameters: 0 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Primary outcome measures
- 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]
- Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2) [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) [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) [Time frame: Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Riley Hospital for Children — Indianapolis
Identifiers
NCT: NCT06310213 · 17368