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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.
Condition(s) studied
Reperfusion InjuryPost Cardiac Arrest Brain Injury
Investigational drug(s) / intervention(s)
LUTICIA - Light Utilization COX-Inhibitory Device)
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.
Study 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. 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.
Eligibility
Inclusion Criteria
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.
* 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 Criteria:
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.
* 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.
Primary outcome measure(s)
- Safety Endpoint: Scalp Temperature — 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 — 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 — 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) — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Children's Hospital of Michigan (Detroit) |
Detroit |
Michigan |
|