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Cool Prime Comparative Effectiveness Study for Mild HIE

Join the Cool Prime Study for mild HIE treatment comparison!

Recruiting
35 years and older
All
Phase N/A

The study aims to help babies with mild HIE (Hypoxic-Ischemic Encephalopathy), a condition where a baby's brain doesn't get enough oxygen and blood. It will compare two treatments: Therapeutic Hypothermia (TH), which cools the baby's body, and normothermia, which keeps the body at normal temperature. The study will look at how these treatments affect the baby's development by the time they are 2 years old and any side effects they might have on the family.

Key Points:

  • The study includes 460 babies and lasts until they are 2 years old.
  • Babies can join if they are born after 35 weeks, show signs of mild HIE, and have specific blood test results.
  • Babies with severe conditions, very low birth weight, or certain medical issues cannot participate.

Doctors will decide which treatment each baby gets depending on the practice at their hospital. This study will help understand which treatment works better and its effects on the baby and family. If you think your baby might fit, talk to your doctor for more information.

Study details
    Mild Hypoxic Ischemic Encephalopathy of Newborn

NCT04621279

University of Texas Southwestern Medical Center

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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