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The PROTECT-HIE Pilot Trial

RecruitingPhase 2Ages 1 Day - 1 DayAllUniversity of Alberta
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In plain words

What the trial is, and whether it could suit you

Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart. To reduce brain injury, babies with HIE are treated with therapeutic hypothermia, a standard treatment in which the baby's body temperature is carefully lowered for several days. While cooling helps protect the brain, many babies with HIE still develop heart problems and low blood flow, which may worsen outcomes. Doctors often use medications to support the heart and circulation in these babies, but there is no clear agreement on which medication works best or when it should be started. One commonly used medication is dobutamine, which helps the heart pump more effectively. Dobutamine is already used in newborn intensive care units when babies show signs of hea

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Newborns with hypoxemic ischemic encephalopathy (HIE) receiving therapeutic hypothermia (TH). Exclusion Criteria: 1. Congenital abnormality 2. known contraindication of dobutamine * Left ventricular outflow tract dynamic obstruction * Hypersensitivity to dobutamine * Uncorrected tachyarrhythmias or ventricular fibrillation 3. Newborns who are already started on inotropes at the time of randomization. 4. Parental refusal to consent to participate
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What it tests

  • Dobutamine
  • TnECHO
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Where

2 sites
Philip C. Etches Neonatal Intensive Care Unit (Royal Alexandra Hospital)
Edmonton, Canada
Royal Alexandra Hospital
Edmonton, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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