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Cool Prime Comparative Effectiveness Study for Mild HIE

Join the Cool Prime Study for Mild HIE treatment research.

Recruiting
35 years and older
All
Phase N/A

Mild HIE (Hypoxic-Ischemic Encephalopathy) is a condition that affects newborn babies when their brain doesn't get enough oxygen. This study is exploring the effectiveness of Therapeutic Hypothermia (TH), a treatment that cools the baby's body to help protect the brain. The study compares this treatment with keeping the baby at normal body temperature, called normothermia, to see which helps babies develop better by age 2.

To be part of this study, babies must be born at or after 35 weeks, show mild brain problems soon after birth, and have certain signs of oxygen problems. The study will follow 460 babies over two years to check their development and any side effects on families. The decision to use TH or normothermia will depend on local practices at 15 different hospitals.

  • The study lasts for 2 years and involves regular check-ins on the baby's development.
  • It does not involve extra treatments beyond local hospital practices.
  • Understanding the risks and benefits of TH may help families decide on participation.
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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