Hypoxic-Ischemic Encephalopathy

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24 Hypoxic-Ischemic Encephalopathy Trials Near You

Power is an online platform that helps thousands of Hypoxic-Ischemic Encephalopathy patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

Cooling Therapy for Pediatric Cardiac Arrest

Columbus, Ohio
This trial is testing if cooling the body can help protect the brains of children who are in a coma after a heart attack. The researchers believe that keeping the body cool might help more children recover well or improve the recovery of those already doing well.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:2 - 17

900 Participants Needed

Therapeutic Hypothermia for Cardiac Arrest

Columbus, Ohio
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

1158 Participants Needed

RLS-0071 for Hypoxic-Ischemic Encephalopathy

Cleveland, Ohio
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:< 10

42 Participants Needed

Physical Therapy for Infant Motor Delay

Chicago, Illinois
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \[an 8-point difference is considered a clinically meaningful difference\] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:33 - 48

222 Participants Needed

Dexmedetomidine for Neonatal Encephalopathy

Hamilton, Ontario
About \~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process. The degree of brain injury that ensues in the first 72 hours after the injury is directly proportional to the severity of long-term childhood disabilities (e.g., cerebral palsy and developmental delays). Whole-body cooling during the first 3 days of life is proven effective in reducing the severity of brain injury. However, cooling therapy leads to pain, shivering, stress, and discomfort. The best way to alleviate the pain and agitation of cooled newborns is unknown. Standard practice is to provide morphine infusion to reduce pain. Recently, a new drug called "dexmedetomidine" has been tested in small studies and has been found to be safe during cooling in newborns. Dexmedetomidine has added beneficial effects such as anti-inflammation, faster recovery, and shorter hospital stays. This study is going to test the feasibility of conducting a future clinical trial to compare the effects of using Dexmedetomidine versus morphine in the management of cooling-related pain/agitation on the severity of brain injury in the first week of life. The study will also examine the effect of dexmedetomidine compared to morphine on short-term clinical outcomes, parental experiences and developmental outcomes at 1 year.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:< 20

50 Participants Needed

Virtual Intervention for Infants with Cerebral Palsy

Toronto, Ontario
This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:4 - 5

150 Participants Needed

Caffeine for Newborn Brain Injury

Chapel Hill, North Carolina
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1
Age:< 24

16 Participants Needed

Antiseizure Medication for Severe Brain Injury

Chapel Hill, North Carolina
The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of consciousness. The main questions it aims to answer are: * Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population? * What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity? Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting

54 Participants Needed

Vagus Nerve Stimulation in Children

Saint Louis, Missouri
The goal of this clinical trial is to learn about brain waves during transauricular vagus nerve stimulation (taVNS) in healthy children. The main questions it aims to answer are: * What is the safety, tolerability, and physiological response of taVNS in children? * Does the electroencephalogram (EEG) change during taVNS? Participants will * undergo a brief titration session where taVNS will be titrated to below perceptual threshold * receive one session of 30 minutes of taVNS * undergo clinical EEG monitoring during taVNS * Continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes * Answer tolerability questions before, during and after 30 minute taVNS session
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:7 - 18

10 Participants Needed

Abecedarian Approach for Premature Birth

Madison, Wisconsin
The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:< 5

100 Participants Needed

Sildenafil for Neonatal Encephalopathy

Montreal, Quebec
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly. This life-threatening condition accounts for nearly 1 out of 4 deaths of all babies around the world, and often leads to severe brain damage, cerebral palsy, epilepsy, and trouble with learning and functioning in everyday life. At this time, no treatment is available to repair the brain damage caused by asphyxia. Excitingly, a drug called sildenafil (Viagra®) is already given safely to babies who suffer from increased blood pressure in their lungs' vessels. Recent studies using a laboratory model of asphyxia at birth suggest that sildenafil may also repair the brain damage caused by asphyxia. Similarly, recent small studies have shown that it is both feasible and safe to give sildenafil to human babies, who suffered from asphyxia at birth. These studies also highlight the first promising signs that sildenafil may improve how the brains of these babies work, which is consistent with the abovementioned laboratory studies. On the basis of these previous researches, the investigators predict that sildenafil can repair the damage to a baby's brain. The investigators will test whether sildenafil can be safely given to a large group of human babies who suffer from asphyxia at birth, and will confirm whether sildenafil improves or not how their brains and hearts/lungs work. This project will enable to determine whether sildenafil is a promising treatment for repairing brain damage in babies who suffer from asphyxia at birth. This project may also provide new solutions for these babies to improve their future life.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:0 - 48

60 Participants Needed

Hyperfine MRI for Detecting Brain Injury in Pediatric ECMO Patients

Kansas City, Missouri
The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:0 - 17

30 Participants Needed

Levetiracetam for Neonatal Seizures

Minneapolis, Minnesota
This trial aims to find the safest and most effective dose of Levetiracetam (LEV) for treating seizures in newborns. LEV works by calming the brain's electrical activity to prevent or reduce seizures. Newborns with seizures will receive LEV, and if seizures continue, they will be given higher doses of LEV. Levetiracetam (LEV) has been studied extensively for its efficacy and safety in treating seizures across various age groups, including neonates, infants, children, and adults.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:< 1

133 Participants Needed

Metformin for Infant Brain Injury

Boston, Massachusetts
Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.
Stay on current meds
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:3 - 6

30 Participants Needed

Melatonin for Neonatal Hypoxic-Ischemic Encephalopathy

Gainesville, Florida
Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. Therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. One potential agent is melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has many other effects that may benefit infants with HI injury. Melatonin serves as a free radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes. Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in turn minimizing cell death and improving outcomes. The research study will evaluate the neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:< 6

70 Participants Needed

Theophylline for Hypoxic-Ischemic Encephalopathy

Oklahoma City, Oklahoma
Acute kidney injury is a significant complication for infants who experience hypoxic ischemic encephalopathy, being associated with increased rates of death and prolonged hospitalization. This pilot study of theophylline administration soon after birth for the prevention of kidney injury will lay the foundation for the conduct of a larger clinical trial that seeks to identify a theophylline as a novel therapy to prevent kidney injury in thousands of at-risk infants.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:1 - 18

30 Participants Needed

Genome Sequencing for Hypoxic-Ischemic Encephalopathy

Houston, Texas
Perinatal hypoxic-ischemic encephalopathy is a rare severe condition in which neonates present with encephalopathy and a clinical history suggestive of prenatal or perinatal hypoxic-ischemic injury. Emerging evidence suggests that genetic conditions are frequently identified in cases of perinatal HIE; however, it is unclear which neonates with this diagnosis warrant genetic testing. This study will offer clinical genome sequencing to neonates with HIE who are undergoing total body cooling (therapeutic hypothermia) and their parents.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:0 - 1

25 Participants Needed

Stem Cell Therapy for Traumatic Brain Injury

Houston,, Texas
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 55

51 Participants Needed

Stem Cell Therapy for Brain Injury

Houston, Texas
This trial is testing the safety and effects of infusing special stem cells (HB-adMSC) into adults with brain injuries. The goal is to see if these stem cells can help repair brain damage and reduce inflammation, potentially improving thinking and movement abilities. Researchers will look at changes in brain structure and function to determine the treatment's effectiveness.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:18 - 55

24 Participants Needed

Dexmedetomidine for Neonatal Encephalopathy

Provo, Utah
Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure. Providing optimal sedation while neonates are undergoing therapeutic hypothermia (TH) may be beneficial but also presents therapeutic challenges. While there is evidence from animal models of brain injury and clinical trials in adults to support the safety and neuroprotective properties of dexmedetomidine (DMT), there are no published large clinical trials demonstrating safety and efficacy of DMT use in neonates with hypoxic-ischemic encephalopathy (HIE) during treatment with TH. This study is innovative in proposing a Phase II, 2-arm trial providing the opportunity to evaluate the use of DMT as compared to the use of morphine for sedation and pain management for babies undergoing TH. We propose to confirm optimal DMT dosing by collecting opportunistic pharmacokinetics (PK) data and determine safety of DMT in this population. These data will inform a larger phase III efficacy trial.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:< 24

50 Participants Needed

Why Other Patients Applied

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

IZ
Healthy Volunteer PatientAge: 38

"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

HZ
Arthritis PatientAge: 78

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40

"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

ZS
Depression PatientAge: 51

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

Therapeutic Hypothermia for Neonatal Encephalopathy

Loma Linda, California
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are \< 6 hours of age. Neurodevelopmental outcome will be assessed at 12-14 months of age. The study will enroll 68 neonates randomized to therapeutic hypothermia or normothermia across 5 centers in California.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Age:< 6

68 Participants Needed

Spinal Stimulation + Mobility Devices for Cerebral Palsy

Seattle, Washington
This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:4 - 70

20 Participants Needed

Neuromonitoring for Hypoxic-Ischemic Brain Injury

Vancouver, British Columbia
This trial evaluates how well oxygen gets from the blood into the brain in patients who have had a cardiac arrest. It focuses on patients with brain injury due to lack of oxygen, checking both blood flow and oxygen movement into brain cells, as well as looking at markers for brain injury and inflammation.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:19+

40 Participants Needed

Burst Suppression Therapy for Seizures after Cardiac Arrest

San Francisco, California
RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2

30 Participants Needed

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Frequently Asked Questions

How much do Hypoxic-Ischemic Encephalopathy clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Hypoxic-Ischemic Encephalopathy clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Hypoxic-Ischemic Encephalopathy trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Hypoxic-Ischemic Encephalopathy is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Hypoxic-Ischemic Encephalopathy medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Hypoxic-Ischemic Encephalopathy clinical trials?

Most recently, we added Dexmedetomidine for Neonatal Encephalopathy, Abecedarian Approach for Premature Birth and Metformin for Infant Brain Injury to the Power online platform.

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