Hydrocephalus in InfantsNCT06310213
Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
A study testing Non-Invasive Pressure Monitor in people with Hydrocephalus in Infants, run by Indiana University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Hydrocephalus in Infants
- What is being tested?
- Non-Invasive Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being monitored for hydrocephalus, or healthy controls
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
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.
- Conditions
- Hydrocephalus in Infants
- Being tested
- Non-Invasive Pressure Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Pressure MonitorDevice
Modified smart soft contact lens and cap with reader coil
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 Control | Active comparator | Intervention at single time point not to interfere with standard of care procedures Receives: Device: Non-Invasive Pressure Monitor |
| Aim 1 Hydrocephalus | Experimental | 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 Receives: Device: Non-Invasive Pressure Monitor |
| Aim 2 Hydrocephalus, Shunt surgery | Experimental | Intervention pre- and post-operatively Receives: Device: Non-Invasive Pressure Monitor |
| Aim 3 Hydrocephalus, EVD ICP monitor | Experimental | Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference) Receives: Device: Non-Invasive Pressure Monitor |
| Aim 4 Hydrocephalus, Reservoir surgery | Experimental | Intervention pre- and post- ventricular reservoir tap(s) Receives: Device: Non-Invasive Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)
ICP readings from the device will be compared to standard of care assessments and measurements in healthy control patients and hydrocephalus patients
Measured: Day 1, continuously measured for up to 4 hours
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)
ICP readings from the device will be compared to standard of care assessments and measurements in patients undergoing shunt insertion
Measured: Continuously measured for up to 4 hours prior to shunt surgery and continuously measured for up to 4 hours after shunt surgery
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure during hydrocephalus evaluation (Aim 3)
ICP readings from the device will be compared to standard of care assessments and measurements in patients with an EVD/ICP monitor
Measured: Continuously measured for up to 4 hours while EVD/ICP monitoring is in place
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)
ICP readings from the device will be compared to standard of care assessments and measurements in patients with a reservoir, pre- and post-tap
Measured: Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start24 Jan 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus in InfantsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Aim 1: Comparison of neonates and infants with hydrocephalus and without Aim 2: Using smart soft contact lens (SSCL) for pre- and post-operative measurements on neonates and/or infants managed operatively (shunt placement) Aim 3: Direct validation by comparing SSCL to external ventricular drain (EVD) intracranial pressure (ICP) monitoring Aim 4: Using SSCL for pre- and post- reservoir tap measurements on neonates and/or infants managed operatively (reservoir placement) Aim 1: 10 patients per arm, two arms Aim 2: 5-10 patients, one arm Aim 3: 5-10 patients, one arm Aim 4: 5-10 patients, one arm
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jignesh Tailor, Indiana University
- Investigators
- Jignesh Tailor, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310213
- Sponsor's protocol ID
- 17368
- Status last verified
- Sep 2025
- First submitted
- 8 Mar 2024
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
- ClinicalTrials.gov ID
- NCT06310213
- Acronym / sponsor ID
- 17368
- Conditions
- Hydrocephalus in Infants
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Aim 1: Comparison of neonates and infants with hydrocephalus and without Aim 2: Using smart soft contact lens (SSCL) for pre- and post-operative measurements on neonates and/or infants managed operatively (shunt placement) Aim 3: Direct validation by comparing SSCL to external ventricular drain (EVD) intracranial pressure (ICP) monitoring Aim 4: Using SSCL for pre- and post- reservoir tap measurements on neonates and/or infants managed operatively (reservoir placement) Aim 1: 10 patients per arm, two arms Aim 2: 5-10 patients, one arm Aim 3: 5-10 patients, one arm Aim 4: 5-10 patients, one arm
| Arm | Type | Receives |
|---|---|---|
| Aim 1 Control | Active comparator | Device: Non-Invasive Pressure MonitorIntervention at single time point not to interfere with standard of care procedures |
| Aim 1 Hydrocephalus | Experimental | Device: Non-Invasive Pressure MonitorIntervention 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 |
| Aim 2 Hydrocephalus, Shunt surgery | Experimental | Device: Non-Invasive Pressure MonitorIntervention pre- and post-operatively |
| Aim 3 Hydrocephalus, EVD ICP monitor | Experimental | Device: Non-Invasive Pressure MonitorIntervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference) |
| Aim 4 Hydrocephalus, Reservoir surgery | Experimental | Device: Non-Invasive Pressure MonitorIntervention pre- and post- ventricular reservoir tap(s) |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Being monitored for hydrocephalus, or healthy controls
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Pressure MonitorModified smart soft contact lens and cap with reader coil | Device | Aim 1 Control, Aim 1 Hydrocephalus, Aim 2 Hydrocephalus, Shunt surgery, Aim 3 Hydrocephalus, EVD ICP monitor, Aim 4 Hydrocephalus, Reservoir surgery |
Primary outcome
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)
Time frame: Day 1, continuously measured for up to 4 hours
ICP readings from the device will be compared to standard of care assessments and measurements in healthy control patients and hydrocephalus patients
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)
Time frame: Continuously measured for up to 4 hours prior to shunt surgery and continuously measured for up to 4 hours after shunt surgery
ICP readings from the device will be compared to standard of care assessments and measurements in patients undergoing shunt insertion
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure during hydrocephalus evaluation (Aim 3)
Time frame: Continuously measured for up to 4 hours while EVD/ICP monitoring is in place
ICP readings from the device will be compared to standard of care assessments and measurements in patients with an EVD/ICP monitor
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)
Time frame: Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping
ICP readings from the device will be compared to standard of care assessments and measurements in patients with a reservoir, pre- and post-tap
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jignesh Tailor principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Pressure Monitor in people with Hydrocephalus in Infants, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1) (time frame: Day 1, continuously measured for up to 4 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.