Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of North Carolina, Chapel Hill
With
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
In a previous phase I trial (NCT03913221), the investigators characterized the pharmacokinetics (PK) of caffeine in the setting of HIE and therapeutic hypothermia using a population PK model. This is an open-label study of caffeine citrate in neonates with HIE to validate the population PK model and determine optimal dosing for HIE.
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented informed consent from parent or guardian
≥ 36 weeks gestational age at birth
Receiving therapeutic hypothermia for a diagnosis of HIE
Intravenous (IV) access
Postnatal age \< 24 hours
You may not be if
Receiving \> 1 anti-epileptic drug for seizures
Sustained (\>4 hours) heart rate \> 180 beats per minute
