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

Hydrocephalus in Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310213
• Other study ID #: 17368
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: Clinical Research Coordinator
• Phone: 317-944-6201
• Email: mkillin[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: July 1, 2028
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus in Infants

Intervention

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

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of modified smart soft contact lens evaluation of external intracranial pressure	ICP readings from the device will be compared to standard of care assessments and measurements across each arm and aim.	Within 12 months of final enrollment