[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06310213":3,"trial-entities:NCT06310213":87,"trial-summary:NCT06310213":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":14,"eligibility_criteria":59,"std_ages":68,"locations":70,"central_contacts":80,"overall_officials":81,"references":85,"see_also_links":86},"NCT06310213","17368","Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus","ENROLLING_BY_INVITATION","2029-01-01","2025-09","2025-10-08","2025-01-24","Indiana University","OTHER",false,"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:\n\n* Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without\n* 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\u002For pre- and post-operatively, as applicable.",null,[18],"Hydrocephalus in Infants",[],"INTERVENTIONAL","SCREENING",[23],"NA",{"count":25,"type":26},25,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Non-Invasive Pressure Monitor","Modified smart soft contact lens and cap with reader coil",[33,34,35,36,37],"Aim 1 Control","Aim 1 Hydrocephalus","Aim 2 Hydrocephalus, Shunt surgery","Aim 3 Hydrocephalus, EVD ICP monitor","Aim 4 Hydrocephalus, Reservoir surgery",[39,43,47,51],{"measure":40,"description":41,"timeFrame":42},"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","Day 1, continuously measured for up to 4 hours",{"measure":44,"description":45,"timeFrame":46},"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","Continuously measured for up to 4 hours prior to shunt surgery and continuously measured for up to 4 hours after shunt surgery",{"measure":48,"description":49,"timeFrame":50},"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\u002FICP monitor","Continuously measured for up to 4 hours while EVD\u002FICP monitoring is in place",{"measure":52,"description":53,"timeFrame":54},"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","Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping",[],"ALL","0 Months","12 Months",{"inclusion":60,"exclusion":62,"raw_text":67},[61],"Being monitored for hydrocephalus, or healthy controls",[63,64,65,66],"Known hypersensitivity to materials used in the contact lens and\u002For adhesive","Open\u002Fclosed wounds at\u002Fnear the anterior fontanelle","Anterior fontanelle is closed","Other conditions deemed relevant by the medical team","Inclusion Criteria:\n\n* Being monitored for hydrocephalus, or healthy controls\n\nExclusion Criteria:\n\n* Known hypersensitivity to materials used in the contact lens and\u002For adhesive\n* Open\u002Fclosed wounds at\u002Fnear the anterior fontanelle\n* Anterior fontanelle is closed\n* Other conditions deemed relevant by the medical team",[69],"CHILD",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"Riley Hospital for Children","Indianapolis","Indiana","46202","United States",{"lat":78,"lon":79},39.76838,-86.15804,[],[82],{"name":83,"affiliation":12,"role":84},"Jignesh Tailor","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":88,"biomarkers":90},[89],"Hydrocephalus",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]