Dallas, TXNCT04621279Now EnrollingIRB Ready

Mild Hypoxic Ischemic Encephalopathy of Newborn Clinical Trial in Dallas, TX

Access cutting-edge mild hypoxic ischemic encephalopathy of newborn treatment through this clinical trial at a research site in Dallas. Study-provided care at no cost to qualified participants.

Sponsored by University of Texas Southwestern Medical Center

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related mild hypoxic ischemic encephalopathy of newborn treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Dallas

    Convenient for TX 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 Dallas site if eligible
  4. 4Begin participation

About This Mild Hypoxic Ischemic Encephalopathy of Newborn Study in Dallas

To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.

Sponsor: University of Texas Southwestern Medical Center

Who Can Participate

Inclusion Criteria

Infants must meet all 3 inclusion criteria
Neonates born at ≥ 36 0/7 weeks
Mild Encephalopathy on neonatal neurologic exam within 6 hours after birth: defined as presence of at least 2 signs of mild, moderate, or severe encephalopathy with no more than 2 signs in the moderate or severe category.
Perinatal Acidosis based on at least one of the following (A or B):
pH ≤ 7.00 in any cord or first infant gas (arterial, venous, or capillary) within ≤ 60 min OR base deficit ≥ 16 in any cord or first infant gas (arterial, venous or capillary) within ≤ 60 min
If pH is between 7.01 and 7.15, OR base deficit is between 10 and 15.9 mmol/liter, OR blood gas is not available, an acute perinatal event is an additional criteria required (see below definition) An acute perinatal event is defined by at least one of the following:
Apgar score at 10 min ≤ 5
Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, or positive pressure ventilation)
Uterine rupture, placental abruption, cord accident (prolapse, rupture, knot or tight nuchal cord)
maternal trauma, maternal hemorrhage, or cardiorespiratory arrest
fetal exsanguination from either vasa previa or feto-maternal hemorrhage, shoulder dystocia
Any evidence suggestive of acute perinatal event. Infants are still eligible for enrollment in the COOLPRIME study if the cord or infant's first blood gas (arterial, venous, or capillary) is obtained \>60 minutes of life.

Exclusion Criteria

Gestational age at birth \< 36 0/7 weeks
Birth weight \< 1800gm
Head circumference \<30cm
Congenital or chromosomal anomaly associated with abnormal neurodevelopment or death
Moderate or Severe HIE of 3 or more moderate or severe abnormalities on COOLPRIME Sarnat exam within 6 hours of life
Any seizures within first six hours of life
Redirection of care is being considered

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 Dallas?

Yes, this clinical trial (NCT04621279) has an active research site in Dallas, TX 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.

Mild Hypoxic Ischemic Encephalopathy of Newborn Treatment Options in Dallas, TX

If you're searching for mild hypoxic ischemic encephalopathy of newborn treatment options in Dallas, TX, this clinical trial (NCT04621279) 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 Dallas research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mild hypoxic ischemic encephalopathy of newborn 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 mild hypoxic ischemic encephalopathy of newborn clinical trials near you to find additional studies recruiting in your area.

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