A Study of Experimental Medicine Topiramate in Newborns Receiving Whole Body Cooling for Encephalopathy (type of brain damage)

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Age: -1 to -1 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Neonatal Encephalopathy, newborn, newborn brain damage, Hypoxic Ischemic Encephalopathy
Type: Drug study, Phase [/1/,/ /2/]
Target:
42 Participants
Investigator:
Description
This study examines the use of an antiepileptic drug called topiramate. It will be studied in babies with neonatal encephalopathy who receive whole body cooling.

Topiramate is a drug that might limit damage to the brain while still letting the brain develop normally. It is not known whether it will really help babies with perinatal depression or neonatal encephalopathy. The use of Topiramate in this study is considered experimental.

We hope to learn:
- if it will reduce seizures (convulsions),
- if it will quicken the recovery from perinatal depression/ neonatal encephalopathy,
- if it will improve long-term development.
This study requires

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.

Who can participate

Inclusion criteria:

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

Exclusion criteria:

  1. Known congenital myopathy
  2. Known congenital neuropathy
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You as Parents will be asked to have your baby participate for a period of 5 days in which the study drug/Topiramate or placebo is administered. You and your baby are expected to come to our clinic for 1 hour follow up test when your baby is 9, 18 and 27 months old.
Recruitment period
From July 28, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Sameeia Iqbal
Research Topic
Conditions:
  • Hypoxic Ischemic Encephalopathy

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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