Home Diseases and Conditions Hypoxic-Ischemic Encephalopathy of Prematurity (HIEP)

Hypoxic-Ischemic Encephalopathy of Prematurity (HIEP)

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound research for this condition is in the laboratory phase and is not yet available for patients.

Focused Ultrasound Therapy 

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with hypoxic injury due to prematurity. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound enhance the diffusion of the sodium butyrate covered nanoparticles that have shown in preclinical models to dramatically reduce the infarct size that comes from the hypoxic state.  While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

The primary options for treatment of HIEP are limited, and typically the infarction size is not able to be controlled with current treatment.  

For certain patients, focused ultrasound could provide a non-invasive alternative to current care that may decrease the morbidity of this difficult situation.  

Advantages

  • Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  
  • Focused ultrasound can reach the desired target without damaging surrounding tissue. 
  • It can be repeated, if necessary. 

Clinical Trials 

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of HIEP.  

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.  

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for HIEP is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Zhao J, Zhang J, Hou L, Yang C, Jiang L, Liang D. Nanoparticle-mediated sodium butyrate delivery for repairing hypoxic-ischemic brain injury in premature infants. Mater Today Bio. 2025 Mar 14;32:101665. doi: 10.1016/j.mtbio.2025.101665. eCollection 2025 Jun. PMID: 40230649 

Click here for additional references from PubMed.