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.
In advance of the IHCA, a consent form signed by the Legally Authorized Representative (LAR) such as a parent/guardian will be attained.
Age greater than 48 hours and less than 1 year (with a corrected gestational age of at least 38 weeks).
Greater than or equal to 2.5 kg body weight.
Acquired or congenital heart disease.
The Legally Authorized Representative does not speak English or Spanish
The LUCID cap is impossible to place within two (2) hours of ROC.
Preterm neonates (with a corrected gestational age of less than 38 weeks) due to the potential incompatibility with cap sizes, lack of information on depth of targeted brain structures, potential for waveguide overlap, and increased skin frailty.
Patients with a head size outside of the range of cap requirements: 32-49cm.
Single group
LUTICIA - Light Utilization COX-Inhibitory Device)
DeviceLight 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.
Safety Endpoint: Scalp Temperature
LUCID is designed to monitor and record scalp surface temperature directly at the light delivery patient interface. A control temperature probe will be placed with a small adhesive patch on the skin below the jaw to measure patient skin temperature at a location remote from treatment. A temperature deviation less than 2°C at the control site throughout the treatment will be an indicator of safety success.
Change from Baseline in Pediatric Cerebral Performance Category (PCPC) Scale
The PCPC is a 6-point scale of increasing disability (1=good/normal, 6=death). This scale is used to assess neurologic functioning.
Change from Baseline in Pediatric Overall Performance Category (POPC) Scale
The POPC is a 6-point scale of increasing disability (1=good/normal, 6=death). This scale is used to assess overall health status. Assessments will be conducted at discharge, 3 months, 1 year, and 2 years post-intervention.
Change from Baseline in Vineland Adaptive Behavior Scale III (VABS-3)
Description: The VABS-3 is an assessment tool used to evaluate adaptive behavior and functional skills.
Secondary Endpoint 1: Number of Participants With Local Scalp Wound Development
Incidence of local wound development as determined by clinical examination: The scalp will be examined prior to placing the LUCID cap, every 30 minutes during the treatment, at the time of removal of the cap, 6-8 hours later, daily for 7 days, weekly through day 28 (or PICU/CICU discharge, whichever occurs first). If wound development occurs, documentation will include location, stage, size, base tissues, exudates, edge/perimeter, pain and evidence of infection. Documentation of wounds and treatment will be gathered by hospital clinicians and included in the study report. Absence of local wound development will be an indicator of safety success. Per protocol, the scalp will be examined prior to placing the cap, every 30 minutes during treatment, at removal, 6-8 hours later, and through Day 28. "Wound development" includes documentation of location, stage, size, and infection. Absence of local wound development is an indicator of safety success.
Secondary Endpoint 2: All-Cause 28-Day Mortality
All-cause mortality at day 28 after ROC will be recorded and compared to historical controls. No numerical increase in mortality compared to historical controls will be an indicator of safety success
Secondary Endpoint 3: Feasibility of Protocol Adherence: Proportion of Participants Completing Treatment
Number of participants who successfully initiated and completed the intended 2-hour LUCID treatment protocol. Adherence includes documented time to placement (interval between ROC and treatment initiation) and any deviations or interruptions to the 2-hour duration (e.g., EEG placement). Adherence to the LUCID protocol will be monitored including use of the LUCID cap if the patient is deemed eligible and consented. Time to placement of the LUCID cap will be documented including the interval between the time of ROC and the time LUCID is placed and treatment is initiated. Any deviations to the standard treatment protocol duration of 2 hours will be documented. Any anticipated interruptions (e.g., EEG electrode placement), and unanticipated events will be documented, and details described.
Secondary Endpoint 4: Acceptability
Acceptability will be assessed by a brief survey with the bedside nurse after the LUCID treatment; and with the LAR at the time of completion of the day 7 outcome measures.
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Mitovation, Inc
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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