Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
NCT ID: NCT06310213
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
25 participants
INTERVENTIONAL
2025-01-24
2029-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit
NCT04920175
Nasal High Frequency in Preterm Neonates
NCT06687083
Non-invasive Monitoring of Newborns in the First Hours of Life for the Prevention of SUPC (Sudden Unexpected Postnatal Collapse): Interventional Study With Medical Device
NCT07213401
Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
NCT02863978
Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA
NCT06287710
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Aim 1 Control
Intervention at single time point not to interfere with standard of care procedures
Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Aim 1 Hydrocephalus
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
Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Aim 2 Hydrocephalus, Shunt surgery
Intervention pre- and post-operatively
Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Aim 3 Hydrocephalus, EVD ICP monitor
Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)
Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Aim 4 Hydrocephalus, Reservoir surgery
Intervention pre- and post- ventricular reservoir tap(s)
Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non-Invasive Pressure Monitor
Modified smart soft contact lens and cap with reader coil
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Open/closed wounds at/near the anterior fontanelle
* Anterior fontanelle is closed
* Other conditions deemed relevant by the medical team
0 Months
12 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jignesh Tailor
Assistant Professor of Neurological Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jignesh Tailor
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Riley Hospital for Children
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17368
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.