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

Indiana University

Status: Invitation-only

Conditions: Hydrocephalus in Infants

Treatments: Device: Non-Invasive Pressure Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06310213

17368

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 5 patient groups

Aim 1 Control

Active Comparator group

Description:

Intervention at single time point not to interfere with standard of care procedures

Treatment:

Device: Non-Invasive Pressure Monitor

Aim 1 Hydrocephalus

Experimental group

Description:

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

Treatment:

Device: Non-Invasive Pressure Monitor

Aim 2 Hydrocephalus, Shunt surgery

Experimental group

Description:

Intervention pre- and post-operatively

Treatment:

Device: Non-Invasive Pressure Monitor

Aim 3 Hydrocephalus, EVD ICP monitor

Experimental group

Description:

Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)

Treatment:

Device: Non-Invasive Pressure Monitor

Aim 4 Hydrocephalus, Reservoir surgery

Experimental group

Description:

Intervention pre- and post- ventricular reservoir tap(s)

Treatment:

Device: Non-Invasive Pressure Monitor