Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310213
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
Non-Invasive Pressure Monitor for Neonates Infants at Risk of Developing Hydrocephalus
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Non-Invasive Pressure Monitor for Neonates Infants at Risk of Developing Hydrocephalus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor pre- and post-operatively as applicable
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 andor pre- and post-operatively as applicable
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None