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Could a light cap save infant brains after cardiac arrest?

NCT ID NCT07556939

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a special cap that shines near-infrared light on the heads of infants who have had a cardiac arrest in the hospital. The light is meant to reduce brain injury caused when blood flow returns. The trial will include 30 infants with heart disease and will check if the cap is safe and easy to use in the intensive care unit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
near-infrared light delivered via a special cap (LUCID device)
What this could lead to
If it works, this could lead to a new bedside treatment that reduces brain damage in infants after cardiac arrest.
What could go wrong
This is a very early safety study with only 30 infants, so it is not designed to prove the device works. The treatment is experimental and may not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

48 hours to 1 year

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital of Michigan (Detroit)

    Detroit, Michigan, 48201, United States

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Other studies related to the condition(s) this trial covers.