Reperfusion InjuryLUTICANCT07556939
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.
A study testing LUTICIA - Light Utilization COX-Inhibitory Device) in people with Reperfusion Injury and Post Cardiac Arrest Brain Injury, run by Mitovation, Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 48 hours to 1 year
- Conditions the study is for
- Reperfusion Injury, Post Cardiac Arrest Brain Injury
- What is being tested?
- LUTICIA - Light Utilization COX-Inhibitory Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 15 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 hours to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must meet ALL of the following criteria to be eligible for participation in the study:
- 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.
- Society of Thoracic Surgeons- European Association for Cardio-Thoracic Surgery (STAT) categories 4 and 5" and those patients with medical cardiac conditions with an admission diagnosis of acute heart failure, if blood lactate levels are greater than 3 mmol/L, or if mechanically ventilated within 4 hours of admission.
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- Chest compressions for at least 2 minutes (120 seconds) during IHCA with ROC; Modified Glasgow Coma Scale for Infants and Children will be used to determine eligibility.
- Coma or encephalopathy after ROC. Coma or encephalopathy after ROC, Modified Glasgow Coma Scale for Infants and Children will be used to determine eligibility.
- Requires mechanical ventilation (i.e., via endotracheal tube or tracheostomy).
- The cardiac arrest was unplanned (i.e., not part of cardiac surgical procedure).
- A patient with a condition in which direct contact with the scalp is contraindicated such as decubitus ulcers, cellulitis, cuts, nicks, scratches, or other conditions with disrupted scalp integrity, will not be eligible for treatment, but will be eligible for the study and data collected will be used as control data.
Who cannot join
- Subjects must be EXCLUDED from participation in this study if ANY of the following criteria are met:
- 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.
- Modified Glasgow Coma Scale for Infants and Children motor response of six (infants, normal spontaneous movement) prior to treatment.
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- Duration of chest compressions greater than 60 minutes inclusive of ECMO deployment.
- Pre-existing severe neurodevelopmental deficits with PCPC = 5 or progressive degenerative encephalopathy.
- Central nervous system tumor with ongoing chemotherapy or radiation therapy.
- Pre-existing terminal illness with life expectancy < 3 months.
- Progressive degenerative encephalopathy.
- Cardiac arrest was associated with severe brain, thoracic, or abdominal trauma
- Active and refractory severe bleeding prior to treatment.
- Continuous infusion of epinephrine or norepinephrine at very high doses (≥ 2 μg/kg/minute).
- Patient is newborn with acute birth asphyxia.
- Patient cared for in a neonatal intensive care unit (NICU) after arrest (i.e., would not be admitted to PICU).
- Patient has sickle cell anemia.
- Patient known to have pre-existing cryoglobulinemia.
- Patient known to have progressive degenerative encephalopathy.
- Patient is known to have neurological issues including convulsions/epileptic seizures, intraventricular hemorrhage, Hypoxic-ischemic encephalopathy, periventricular leukomalacia, and retinopathy of prematurity.
- Patient is known to have a recorded temperature at treatment/LDU site out of range.
- Lack of commitment to aggressive intensive care therapies including do not resuscitate orders and other limitations to care.
- History of a prior cardiac arrest with chest compressions for at least two minutes during the current hospitalization but outside the 2-hour window for treatment.
- Patient cared for in a neonatal intensive care unit (NICU) after arrest (i.e., not admitted to pediatric ICU (PICU)/CICU).
- Patients with prior or concurrent enrollment in any other neurotherapeutic trial, which may confound this study's results and expose patients to the unknown risks of multiple investigational treatments.
- Patient participation in a concurrent interventional trial whose protocol, in the judgment of the LUCID investigators, prevents effective application of LUCID, or otherwise significantly interferes with carrying out the LUCID protocol. We will use the Neonatal Adverse Event Severity Scale.
- Previous enrollment in or termination from LUTICA trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital of Michigan (Detroit)
Detroit, Michigan, 48201
Kathy Meert, MD, 313-745-5891, kmeert@dmc.com
About this study
Official title: Light Utilization COX-Inhibitory Device Therapy for Infant Cardiac Arrest (LUTICA Study)
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.
Read the detailed description
LUCID is a device 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. LUCID is compatible with EEG monitoring and protective eye covering. It is an appropriate size and weight for clinical use, and capable of battery operation which will allow patient transport and incorporation into seamless clinical workflow.
The light source and user interface contain laser diodes producing the therapeutic wavelengths with thermoelectric and air cooling to prolong the lifetime of the diodes and provide temperature control. LUCID also contains a user interface/control panel. Power supply is via standard power outlet.
The LUCID control module is equipped with a simple, user-friendly interface for initiating the treatment as well as system feedback to ensure proper function of the device and therapeutic delivery. The system has a main power switch located on the front of the device which engages power to the diode subassemblies, enables system thermoregulation components, and runs a quick system self-check. The healthcare provider will place and secure the cap on the infant's head and connect the light source to the human interface. Once the cap has been properly connected to the light source, the connection indicator will illuminate, signaling that the treatment is ready to initiate. Once treatment is initiated by the user, the user interface will monitor contact, light, and temperature sensors in the cap to ensure the device is operating within designated safe and effective treatment parameters. If abnormalities are detected, the unit will disengage treatment. Clinician oversight is required during the treatment period to monitor the patient and system. Normal system operation shows a visible treatment countdown timer on the front panel to document a full 4-hour treatment. The system logs treatment duration, date and time of treatment for documentation of therapeutic delivery and system performance.
The system will automatically terminate therapeutic NIR light at the end of the 2-hour treatment, and the system will notify the user when treatment has stopped. Errors in the system that would initiate safety shutdown include loss of LDU contact with the patient's skin, light loss or excess at the light delivery patient interface, system overheating, diode failure, or active system cooling failure. The user interface will indicate treatment interruption with an error LED and audio indicator, along with documentation in the run log including the error code with time to document the duration of treatment interruption and the dose the patient received. To provide eye protection during LUCID treatment, eye masks such as the EyeMax-2 or NeoShades (routinely used in infants undergoing phototherapy for hyperbilirubinemia) will be placed on the infant. Eyewear for the clinician is recommended but not required.
The LUCID system consists of 2 primary components:
- Lightbox: This multiple use component generates the 750 (+/- 10) and 940 (+/- 10) nanometer light delivered to the patient via a fiberoptic cable (interface cable) connected to the cap. The Lightbox includes the user interface and control electronics that ensure the specific amount of light is delivered and all safety measures are being performed.
- Cap: This single use device employs light guides that diffuse and direct the light into the patient's head during treatment. The Cap includes silicone waveguides (Light Delivery Units - LDU's) that direct therapeutic light into the patient and returns specific measurements (GOOD CONTACT indicator, temperature, light levels) to the Lightbox.
- Being tested
- LUTICIA - Light Utilization COX-Inhibitory Device)
- Keywords
- infrared light therapy, mitochondrial therapy, photobiomodulation therapy, pediatric brain injury
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| The LUTICA study is a prospective, multi-center, single-arm interventional trial with 3 month follow | Experimental | 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. Receives: Device: LUTICIA - Light Utilization COX-Inhibitory Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours during treatment
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.
Measured: The study will be conducted in hospital at screening, discharge, and then at 3 months, 1 year, and 2 years.
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.
Measured: Assessments will be conducted at screening, 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.
Measured: Assessments will be conducted at screening, discharge, 3 months, 1 year, and 2 years post-intervention.
Change from Baseline in Hammersmith Neonatal Neurological Exam (HNNE) or Hammersmith Infant Neurological Exam (HINE)
The HNNE/HINE is a clinical assessment of neurological function.
Measured: Assessments require an in-person examination and will be conducted at screening, discharge, 3 months, 1 year, and 2 years post-intervention.
Secondary outcomes (9)
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.
Measured: From baseline (pre-treatment) through Day 28 or PICU/CICU discharge
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
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 7 days
Secondary Endpoint 5: Vineland Adaptive Behavior Scales Third Edition
Vineland Adaptive Behavior Scales Third Edition (VABS-3) will be used to obtain a standardized quantifiable measure of neurobehavioral function in survivors.15 VABS-3 uses LAR report to provide age corrected scores in three core domains (communication, daily living, socialization) with a composite score of these domains. Earlier versions of the Vineland (VABS-2) have been used to study infants and children who have experienced a cardiac arrest where death was assigned a score of zero, as will be done in this study.16,17 VABS-3 will be administered as a semi-structured interview with the LAR either in-person or remotely over the telephone or virtual meeting. The time required to complete the subset of questions intended for an infant < 1 year of age is less than 20 minutes. Baseline VABS-3 information will be collected at the time of participant enrollment (prior to IHCA). VABS-3 will also be collected at day 28 post-ROC (or PICU/CICU discharge, whichever occurs first) and 3 mo
Measured: 3 months
Secondary Endpoint 6: Pediatric Resuscitation after Cardiac Arrest Scale
Pediatric Resuscitation after Cardiac Arrest (PRCA) scale will be used to obtain a standardized age appropriate neurologic examination. Neurologic function will be scored (0, normal to 3, severe impairment) in 6 domains. The sensorimotor domain is scored independently for each side of the body. The five other scored domains include other non lateralizing sensorimotor function (encompassing cranial nerve deficits, movement/tone disorder, global delays), language production, language comprehension, cognition, and behavior. Total PRCA scores range from 0-21, with 0 indicating no deficits and 21 indicating maximal deficits. Scores are categorized as 0-3 (no/minimal impairment), 4-7 (mild impairment), 8-11 (moderate impairment), 12-16 (severe impairment), and 17-21 (profound impairment). PRCA exam will be performed near the time of enrollment (prior to IHCA), within the 24-hour period post-ROC, day 28 post-ROC (or PICU/CICU discharge, whichever occurs first), and 3 months.
Measured: 3 months
Secondary Endpoint 7: Neurological Status as Assessed by Murray's EEG Grading Criteria
EEG findings will be graded using Murray's criteria (for neonates) and matching criteria for older patients to assess post-arrest brain function. Evaluation includes the SCORE system for interpretation and documentation of background rhythm, interictal spikes, sleep architecture (spindles/K complexes), and seizure activity.
The protocol also includes: Scalp EEG monitoring will proceed per local protocol for post-arrest care, with typical lead placement at 22-24 hours after ROS. A standard 10-20 EEG system with nine scalp electrodes (Fp1, Fp2, C3, C4, O1, O2, T3, T4, and Cz) will be used following the guidelines endorsed by the ACNS.
Parameters that will be documented are background alpha rhythm; interictal spikes, abnormal interictal rhythmic activity and periodic discharges, and sleep architecture will be qualitatively assessed for sleep spindles and K complexes; electrographic seizures, or clinical seizures.
Measured: 3 months
Secondary Endpoint 8: Incidence of Elevated Neuro-injury Biomarker Levels
Participants' plasma levels for six biomarkers (Neurofilament light chain, GFAP, UCH-L1, NSE, S100b, and tau) are measured 24 (+ 4) hours and 7 days after Return of Circulation (ROC). Levels are compared against established age-matched reference ranges for healthy infants to determine elevation.
Time Frame: 24 hours (+ 4 hours) and 7 days post-ROC
Measured: 24 hours and 7 days
Secondary Endpoint 9: Presence of Ischemic Brain Injury as Assessed by Clinical Neuroimaging (CT/MRI)
Evaluation of brain and brain stem integrity via clinically indicated CT and/or MRI scans. Radiology reports will be reviewed for findings of ischemia-reperfusion injury, including cerebral edema or infarction. This measure will report the number of participants with documented imaging evidence of brain injury during the study period.
The protocol states: Computed tomography (CT) and magnetic resonance imaging (MRI) scans of brain and brain stem, and corresponding radiology reports, that are obtained for clinical purposes at any time during the 3-month study period will be collected.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The LUTICA study is a prospective, multi-center, single-arm interventional trial with 3 month, 1 year, and 2 year follow-up.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitovation, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Kathleen Meert, MD, Principal investigator, Children's Hospital of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556939
- Sponsor's protocol ID
- G240289
- Other IDs
- U44NS125160
- Acronym
- LUTICA
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Will review each study partners procedures on sharing IPD before making this decision.
Publications
Sanderson TH, Wider JM, Lee I, Reynolds CA, Liu J, Lepore B, Tousignant R, Bukowski MJ, Johnston H, Fite A, Raghunayakula S, Kamholz J, Grossman LI, Przyklenk K, Huttemann M. Inhibitory modulation of cytochrome c oxidase activity with specific near-infrared light wavelengths attenuates brain ischemia/reperfusion injury. Sci Rep. 2018 Feb 22;8(1):3481. doi: 10.1038/s41598-018-21869-x.
PubMed 29472564Wider JM, Gruley E, Morse PT, Wan J, Lee I, Anzell AR, Fogo GM, Mathieu J, Hish G, O'Neil B, Neumar RW, Przyklenk K, Huttemann M, Sanderson TH. Modulation of mitochondrial function with near-infrared light reduces brain injury in a translational model of cardiac arrest. Crit Care. 2023 Dec 14;27(1):491. doi: 10.1186/s13054-023-04745-7.
PubMed 38098060
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Utilization COX-Inhibitory Device Therapy for Infant Cardiac Arrest (LUTICA Study)
- ClinicalTrials.gov ID
- NCT07556939
- Acronym / sponsor ID
- LUTICA / G240289
- Keywords
- infrared light therapy, mitochondrial therapy, photobiomodulation therapy, pediatric brain injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mitovation, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2030 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
LUCID is a device 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. LUCID is compatible with EEG monitoring and protective eye covering. It is an appropriate size and weight for clinical use, and capable of battery operation which will allow patient transport and incorporation into seamless clinical workflow.
The light source and user interface contain laser diodes producing the therapeutic wavelengths with thermoelectric and air cooling to prolong the lifetime of the diodes and provide temperature control. LUCID also contains a user interface/control panel. Power supply is via standard power outlet.
The LUCID control module is equipped with a simple, user-friendly interface for initiating the treatment as well as system feedback to ensure proper function of the device and therapeutic delivery. The system has a main power switch located on the front of the device which engages power to the diode subassemblies, enables system thermoregulation components, and runs a quick system self-check. The healthcare provider will place and secure the cap on the infant's head and connect the light source to the human interface. Once the cap has been properly connected to the light source, the connection indicator will illuminate, signaling that the treatment is ready to initiate. Once treatment is initiated by the user, the user interface will monitor contact, light, and temperature sensors in the cap to ensure the device is operating within designated safe and effective treatment parameters. If abnormalities are detected, the unit will disengage treatment. Clinician oversight is required during the treatment period to monitor the patient and system. Normal system operation shows a visible treatment countdown timer on the front panel to document a full 4-hour treatment. The system logs treatment duration, date and time of treatment for documentation of therapeutic delivery and system performance.
The system will automatically terminate therapeutic NIR light at the end of the 2-hour treatment, and the system will notify the user when treatment has stopped. Errors in the system that would initiate safety shutdown include loss of LDU contact with the patient's skin, light loss or excess at the light delivery patient interface, system overheating, diode failure, or active system cooling failure. The user interface will indicate treatment interruption with an error LED and audio indicator, along with documentation in the run log including the error code with time to document the duration of treatment interruption and the dose the patient received. To provide eye protection during LUCID treatment, eye masks such as the EyeMax-2 or NeoShades (routinely used in infants undergoing phototherapy for hyperbilirubinemia) will be placed on the infant. Eyewear for the clinician is recommended but not required.
The LUCID system consists of 2 primary components:
- Lightbox: This multiple use component generates the 750 (+/- 10) and 940 (+/- 10) nanometer light delivered to the patient via a fiberoptic cable (interface cable) connected to the cap. The Lightbox includes the user interface and control electronics that ensure the specific amount of light is delivered and all safety measures are being performed.
- Cap: This single use device employs light guides that diffuse and direct the light into the patient's head during treatment. The Cap includes silicone waveguides (Light Delivery Units - LDU's) that direct therapeutic light into the patient and returns specific measurements (GOOD CONTACT indicator, temperature, light levels) to the Lightbox.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The LUTICA study is a prospective, multi-center, single-arm interventional trial with 3 month, 1 year, and 2 year follow-up.
| Arm | Type | Receives |
|---|---|---|
| The LUTICA study is a prospective, multi-center, single-arm interventional trial with 3 month follow | Experimental | Device: LUTICIA - Light Utilization COX-Inhibitory Device)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. |
Who may qualify
- Ages
- 48 hours to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Subjects must meet ALL of the following criteria to be eligible for participation in the study:
- 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.
Key exclusion criteria (27 listed)
- Subjects must be EXCLUDED from participation in this study if ANY of the following criteria are met:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUTICIA - Light Utilization COX-Inhibitory 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. | Device | The LUTICA study is a prospective, multi-center, single-arm interventional trial with 3 month follow |
Primary outcome
Safety Endpoint: Scalp Temperature
Time frame: 2 hours during treatment
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
Time frame: The study will be conducted in hospital at screening, discharge, and then at 3 months, 1 year, and 2 years.
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
Time frame: Assessments will be conducted at screening, discharge, 3 months, 1 year, and 2 years post-intervention.
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)
Time frame: Assessments will be conducted at screening, discharge, 3 months, 1 year, and 2 years post-intervention.
Description: The VABS-3 is an assessment tool used to evaluate adaptive behavior and functional skills.
Change from Baseline in Hammersmith Neonatal Neurological Exam (HNNE) or Hammersmith Infant Neurological Exam (HINE)
Time frame: Assessments require an in-person examination and will be conducted at screening, discharge, 3 months, 1 year, and 2 years post-intervention.
The HNNE/HINE is a clinical assessment of neurological function.
9 secondary outcomes
Secondary Endpoint 1: Number of Participants With Local Scalp Wound Development
Time frame: From baseline (pre-treatment) through Day 28 or PICU/CICU discharge
Secondary Endpoint 2: All-Cause 28-Day Mortality
Time frame: 28 days
Secondary Endpoint 3: Feasibility of Protocol Adherence: Proportion of Participants Completing Treatment
Time frame: 28 days
Secondary Endpoint 4: Acceptability
Time frame: 7 days
Secondary Endpoint 5: Vineland Adaptive Behavior Scales Third Edition
Time frame: 3 months
Secondary Endpoint 6: Pediatric Resuscitation after Cardiac Arrest Scale
Time frame: 3 months
Secondary Endpoint 7: Neurological Status as Assessed by Murray's EEG Grading Criteria
Time frame: 3 months
Secondary Endpoint 8: Incidence of Elevated Neuro-injury Biomarker Levels
Time frame: 24 hours and 7 days
Secondary Endpoint 9: Presence of Ischemic Brain Injury as Assessed by Clinical Neuroimaging (CT/MRI)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 29472564Sanderson TH, Wider JM, Lee I, Reynolds CA, Liu J, Lepore B, Tousignant R, Bukowski MJ, Johnston H, Fite A, Raghunayakula S, Kamholz J, Grossman LI, Przyklenk K, Huttemann M. Inhibitory modulation of cytochrome c oxidase activity with specific near-infrared light wavelengths attenuates brain ischemia/reperfusion injury. Sci Rep. 2018 Feb 22;8(1):3481. doi: 10.1038/s41598-018-21869-x.
- Background: PubMed 38098060Wider JM, Gruley E, Morse PT, Wan J, Lee I, Anzell AR, Fogo GM, Mathieu J, Hish G, O'Neil B, Neumar RW, Przyklenk K, Huttemann M, Sanderson TH. Modulation of mitochondrial function with near-infrared light reduces brain injury in a translational model of cardiac arrest. Crit Care. 2023 Dec 14;27(1):491. doi: 10.1186/s13054-023-04745-7.
- Corporate Website for Mitovation.comLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Will review each study partners procedures on sharing IPD before making this decision.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Meert, MD principal investigator
Children's Hospital of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUTICIA - Light Utilization COX-Inhibitory Device) in people with Reperfusion Injury and Post Cardiac Arrest Brain Injury, run by Mitovation, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Waddell, BSEE (19522213333, twaddell@mitovation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint: Scalp Temperature (time frame: 2 hours during treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07556939, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.