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LUTICA Study: Light Therapy for Infant Brain Injury After Cardiac Arrest

This study is testing a new device called LUCID (Light Utilization COX-Inhibitory Device) for infants who have had a cardiac arrest. The LUCID device uses special near-infrared (NIR) light to help protect the brain from damage that can happen after blood flow returns (reperfusion injury). Researchers want to see if this light therapy is safe and if it can improve how well infants recover after cardiac arrest. They will be looking at things like scalp temperature and how well infants perform on scales that measure their brain and overall function over time. About 30 infants, aged 48 hours to 1 year, who have experienced an in-hospital cardiac arrest, may be able to participate.

Study design
This is an interventional study planning to enroll 30 participants. The phase of the study is not specified.
What's involved
Assessments will be conducted at screening, hospital discharge, and then at 3 months, 1 year, and 2 years after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07556939

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.

Not Yet Recruiting
NAAges 48–1InterventionalPrevention
Mitovation, Inc
~30 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:LUTICIA - Light Utilization COX-Inhibitory Device)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Endpoint: Scalp Temperature
Measured over 2 hours during treatment
+4 more outcomes measured

Conditions

Reperfusion Injury
Post Cardiac Arrest Brain Injury

Explore related trials

Acute heart diseaseCardiac ArrestCongenital Heart DiseaseReperfusion Injury

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Kathleen Meert, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Michigan

Who to contact

Tom Waddell, BSEE
[email protected]
19522213333
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Safety Endpoint: Scalp Temperature2 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) ScaleThe 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) ScaleAssessments 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)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)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.