← Back to Search

Aim 4 Hydrocephalus, Reservoir surgery for Hydrocephalus

N/A

Waitlist Available

Led By Jignesh Tailor

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 12 months of final enrollment

Awards & highlights

Study Summary

This trial aims to test a modified smart soft contact lens in newborns and infants at risk of hydrocephalus. It will determine if the device can differentiate between pressure changes in infants with hydrocephalus

Who is the study for?

This trial is for newborns and infants at risk of hydrocephalus, a condition where fluid builds up in the brain. They must be undergoing standard care for hydrocephalus to participate. The study excludes those who do not meet the specific criteria set by researchers.Check my eligibility

What is being tested?

Researchers are testing a new non-invasive pressure monitor using a smart soft contact lens to track changes in brain pressure in babies with and without hydrocephalus, before and after surgery or other treatments.See study design

What are the potential side effects?

Since this device is non-invasive and used only during evaluations, side effects may be minimal but could include discomfort from wearing the contact lens or skin irritation around the eye area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 12 months of final enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 12 months of final enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 12 months of final enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of modified smart soft contact lens evaluation of external intracranial pressure

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Aim 4 Hydrocephalus, Reservoir surgeryExperimental Treatment1 Intervention

Intervention pre- and post- ventricular reservoir tap(s)

Group II: Aim 3 Hydrocephalus, EVD ICP monitorExperimental Treatment1 Intervention

Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)

Group III: Aim 2 Hydrocephalus, Shunt surgeryExperimental Treatment1 Intervention

Intervention pre- and post-operatively

Group IV: Aim 1 HydrocephalusExperimental Treatment1 Intervention

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

Group V: Aim 1 ControlActive Control1 Intervention

Intervention at single time point not to interfere with standard of care procedures

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

983 Previous Clinical Trials

981,217 Total Patients Enrolled

Jignesh TailorPrincipal InvestigatorIndiana University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to participants older than 20 years of age?

"Eligible candidates for this research trial must be between 0 and 12 months old. There are six trials available to individuals under 18 years of age, along with twenty trials open to those aged over 65."

Answered by AI

Which specific criteria must individuals meet in order to be eligible for participation in this clinical study?

"Eligible participants for this research study must be within the age range of 0 to 12 months and have a diagnosis of hydrocephalus. The trial aims to enroll approximately 25 individuals in total."

Answered by AI

Are participants currently being recruited for enrollment in this clinical trial?

"The current status on clinicaltrials.gov indicates that patient recruitment for this trial is paused. Initially shared on April 1st, 2024, with the latest update made on March 13th of the same year. Although this specific study is not enrolling participants currently, there are a total of 25 other trials actively seeking candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jignesh Tailor 2024. "Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06310213.

All > Hydrocephalus