Gainesville, FLNCT02621944Now EnrollingIRB Ready

Hypoxic Ischemic Encephalopathy Clinical Trial in Gainesville, FL

Access cutting-edge hypoxic ischemic encephalopathy treatment through this early phase 1 clinical trial at a research site in Gainesville. Study-provided care at no cost to qualified participants.

Sponsored by University of Florida

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Expert Care in Gainesville

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hypoxic ischemic encephalopathy treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Gainesville

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Gainesville site if eligible
  4. 4Begin participation

About This Hypoxic Ischemic Encephalopathy Study in Gainesville

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.

Sponsor: University of Florida

Who Can Participate

Inclusion Criteria

Eligible infants are \>36 0/7th weeks gestation,
pH (cord or neonatal) \<7.0,
base deficit \>16 mEq/L,
no available blood gas,
a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15,
base deficit between 10 and 15.9 mEq/L,
infants must have a history of an acute perinatal event,
either a 10-minute Apgar \< 5 or a continued need for ventilation,
All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,
neonates cooled within 6 hours of birth will be included in the study.

Exclusion Criteria

suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,
clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,
a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Gainesville?

Yes, this clinical trial (NCT02621944) has an active research site in Gainesville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hypoxic Ischemic Encephalopathy Treatment Options in Gainesville, FL

If you're searching for hypoxic ischemic encephalopathy treatment options in Gainesville, FL, this clinical trial (NCT02621944) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Gainesville research site is actively enrolling participants for this early phase 1 clinical trial. You'll receive care from experienced hypoxic ischemic encephalopathy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hypoxic ischemic encephalopathy clinical trials near you to find additional studies recruiting in your area.

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