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

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

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.

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