|Age:||-1 to -1 years old|
|Keywords:||Neonatal Encephalopathy, newborn, newborn brain damage, Hypoxic Ischemic Encephalopathy|
|Type:||Drug study, Phase [/1/,/ /2/]|
The following procedures WILL ONLY BE DONE IF YOUR BABY JOINS THE STUDY:
• Your baby will be randomized to get a solution orally once a day for five days. The solution will either be topiramate or placebo.
• A small amount of extra blood (about 1/2 teaspoon) will be taken three times to measure a special protein (UCHL1) that may detect brain injury. This blood will be taken at the same time as your baby needs a routine blood test.
• A small amount of extra blood (less than 1⁄2 teaspoon) will be taken three times to measure the level of topiramate in your baby’s blood. This blood will be taken at the same time as your baby needs a routine blood test.
• A small amount of urine (1 to 3 teaspoons) will be collected from a cotton ball in your baby's diaper to measure a special protein (S100B) three times during the study.
In order to be eligible for cooling the baby must meet all three of the following sets of criteria 1. Be near term (typically ≥34wks gestation) and be aged < 6h old 2. Have signs of early perinatal depression (EITHER 10 minute Apgar score < 5, OR pH < 7.00 within 60mins of age, OR Base Excess < -12 within 60mins of age, OR need respiratory support at 10min of age due to respiratory depression) 3. Have signs of moderate or severe encephalopathy based on either clinical examination or on amplitude integrated aEEG assessment
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.