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Non-invasive Pressure Monitor for Neonates and Infants at Risk of Developing Hydrocephalus
Studying a Device for Infants with Fluid Build-up in the Brain
J
Jignesh Tailor
Primary Investigator
Enrolling By Invitation
1 day - 1 year
All
Phase
N/A
20 participants needed
1 Location
Brief description of study
The purpose of this study is to test a device designed to monitor pressure within the skull of neonates and infants at risk of developing hydrocephalus (fluid and pressure build-up in the brain). The device will measure changes in the anterior fontanelle (soft spot). The study will be conducted in the hospital setting, using the modified SSCL pressure monitor with smart soft contact lens technology to test external ICP in neonates and infants. The focus will be on validating the technology's accuracy, ease of use, and compatibility with current clinical practices.
THIS STUDY IS ENROLLING BY INVITATION ONLY - All children enrolled in this study will be neonates or infants who will be identified through existing patients at Riley Children’s Hospital in Indianapolis, IN under the care of the Principal Investigator, Dr. Jignesh Tailor, or co-investigators Drs. Laurie Ackerman, Saul Wilson, and/or Rabia Qaiser. Parents/guardians of the potential participants will be approached for consent in the hospital setting.
Detailed description of study
Neurosurgery medical staff will place the device on the child’s head for a period of no longer than 4 hours. A smart soft contact lens is placed over the soft spot and a hat with a reader coil is then placed on the head. A section of hair may be shaved before the device is placed, and biosafe adhesive may be applied. The device may be placed at the following times:
• For healthy volunteers:
o A single time that does not interfere with standard of care procedures
• For patients under neurosurgery care:
o During standard of care assessments of soft spot and/or head circumference
o Pre- and post- ventricular reservoir taps
o Pre- and post- operatively
• For healthy volunteers:
o A single time that does not interfere with standard of care procedures
• For patients under neurosurgery care:
o During standard of care assessments of soft spot and/or head circumference
o Pre- and post- ventricular reservoir taps
o Pre- and post- operatively
Monitoring of vital signs, measurement of head circumference, and soft spot assessment may occur at the time the device is placed. Research staff may also review the child’s medical record for information related to their diagnosis. Enrollment will occur over 6 months from the initiation of the study, and the entire study will last a maximum of 24 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy, Hydrocephalus, Riley
-
Age: 1 day - 1 year
-
Gender: All
Inclusion Criteria:
- Male and female patients less than 1 years old, in any distribution
- Neonates & Infants requiring monitoring for hydrocephalus, or healthy controls.
- Neonates & Infants whose parents or guardians have provided informed consent.
- Neonates & Infants with no known allergy or sensitivity to the lens materials and/or adhesive
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
- Male and female patients less than 1 years old, in any distribution
- Neonates & Infants requiring monitoring for hydrocephalus, or healthy controls.
- Neonates & Infants whose parents or guardians have provided informed consent.
- Neonates & Infants with no known allergy or sensitivity to the lens materials and/or adhesive
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
This study investigates a device designed to monitor pressure inside the skull of neonates and infants who are at risk of developing hydrocephalus, which is a condition where there is a build-up of fluid and pressure in the brain. The device measures changes in the anterior fontanelle, also known as the soft spot on a baby's head, using a special contact lens technology.
During the study, medical staff will place the device on the child's head for up to 4 hours. This involves placing a smart soft contact lens over the soft spot and a hat with a reader coil on the head. Some hair might be shaved, and a safe adhesive may be used. The device can be placed during routine care, such as checking the soft spot or head size, before and after certain procedures, or during regular hospital visits.
- Who can participate: Male and female infants under 1 year old needing monitoring for hydrocephalus or as healthy controls can join. Participants must not have allergies to lens materials or adhesives, and parental consent is required.
- Study details: Participants will have a device on their head for monitoring, which includes a smart contact lens and a hat with a reader coil. No placebo is used in this study.
- Study timelines: The study will last 24 months.
Updated on
11 Nov 2025.
Study ID: SNEU-IIR-17368, 17368
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