Light Utilization COX-Inhibitory Device Therapy for Infant Cardiac Arrest (LUTICA Study). The LUCID Device is Used in the Treatment of Ischemic Brain Reperfusion Injury Caused by Cardiac Arrest in Pediatric Patients.

Conditions

• Post Cardiac Arrest Brain Injury
• Reperfusion Injury

Eligibility Criteria

Sex

ALL

Age

48 Hours - 1 Year

Healthy Volunteers

Not accepted

Interventions

• LUTICIA - Light Utilization COX-Inhibitory Device) — DEVICE
  Light Utilization COX Inhibitory Device (LUCID) is a novel medical device intended to safely deliver therapeutic NIR to the infant brain to prevent reperfusion injury. The therapy is designed to deliver therapeutic NIR light (750 nm and 950 nm) to the brain of infants to provide neuroprotection following cardiac arrest and resuscitation. LUCID consists of two distinct parts: (1) Human interface, and (2) Light source and user interface. The human interface will deliver therapeutic NIR light directly to the infant's head. The light delivery areas distribute the light to ensure uniform distribution, dose, and safety.

Study Details

Approximately 15,200 children receive cardiopulmonary resuscitation (CPR) for in-hospital cardiac arrest (IHCA) each year in the United States. Of these, about 60% are less than one year of age. Most IHCA (85-90%) occurs in intensive care units (ICU) or other monitored settings. Risk of IHCA is higher among children with cardiac disease compared to children with other diagnoses. A report based on the Pediatric Cardiac Critical Care Consortium (PC4) registry found 3.1% of children hospitalized in pediatric cardiac ICUs had a cardiac arrest; rates varied from 1% to 5.5 % across sites. Survival to hospital discharge after CA in children included in the PC4 registry was 53%, and lower for medical cardiac patients (37.7%) than for surgical cardiac patients (62.5%). Among survivors of pediatric IHCA, neurologic morbidities are common including cognitive, motor, and adaptive functional deficits. Despite high mortality and morbidity, treatment for children after IHCA is mainly supportive. Preventing fever and hypotension, maintaining normoxia, and treating seizures are emphasized. Ischemia-reperfusion injury to the brain is a primary cause of neurologic morbidity after IHCA. Ischemia-reperfusion leads to increased production of cytotoxic mitochondrial reactive oxygen species (ROS). Recently, specific wavelengths of near infrared light (NIR) (750 nm and 950 nm) have been discovered to partially inhibit cytochrome c oxidase activity (COX), reversibly reducing mitochondrial respiration and generation of ROS. Light Utilization COX Inhibitory Device (LUCID) is a novel medical device intended to safely deliver therapeutic NIR to the infant brain to prevent reperfusion injury. This protocol describes the "LUCID Therapy for Infant Cardiac Arrest" (LUTICA) clinical trial. LUTICA will investigate the safety, feasibility, acceptability, and probable benefit of the LUCID device in infants with acquired or congenital cardiac disease who experience unplanned IHCA. The hypothesis of the LUTICA trial is that application of the LUCID light box and cap immediately following IHCA in infants with acquired or congenital heart disease will be safe, feasible, and acceptable in the ICU setting, and demonstrate probable benefit toward favorable neurological outcomes.

Key Dates

Start date

Jul 15, 2026

Status verified

Apr 2026

Primary completion

Jul 15, 2029

Completion

Jul 15, 2030

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: The LUTICA study is a prospective, multi-center, single-arm interventional trial with 3 month follow
  The study population is infants greater than 48 hours and less than 1 year of age, with acquired or congenital heart disease, who experience IHCA (In Hospital Cardiac Arrest) for two minutes or longer with ROC (Return of Circulation). Because the LUCID device needs to be applied to the infant's head as close to the time of ROC as possible and within 2 hours of ROC, parents/guardians will need to have provided their consent for study participation prior to the infant's IHCA event. Infants will be screened and parents/guardians approached for consent (1) at the infant's pre-operative clinic visit with the cardiovascular surgeon or cardiologist, or (2) after admission to the hospital but prior to the cardiac arrest event.

Primary Outcome Measure

Safety Endpoint: Scalp Temperature [ Time Frame: 2 hours during treatment ]

Central Contacts

• Tom Waddell, BSEE
  19522213333
  [email protected]

Locations (1)

Find similar trials in Detroit, MI

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