PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Caffeine
About this trial
This is an interventional treatment trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Newborns ≥ 35 weeks GA
- Admitted to the ACH NICU less than 24 hours of life
- Receiving active or passive TH or whole-body cooling at 12 hours of life to treat hypoxic ischemic encephalopathy per institutional criteria based on National Institute of Child Health and Human Development criteria
Exclusion Criteria:
- Genetic or congenital condition that affects renal function (e.g., congenital anomalies of the kidney and urinary tract (CAKUT), complex congenital heart disease)
- Diminished capacity or autonomy of the neonate's parents that prevents their ability to give informed consent
- Theophylline, aminophylline, or caffeine exposure prior to enrollment
Status epilepticus as defined by:
- A seizure lasting longer than 30 minutes
- Use of a continuous infusion of antiepileptic medication (i.e., midazolam)
- The use of 3 or more antiepileptic medications for the indications of intractable seizures
Sites / Locations
- Arkansas Children's Hospital
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Arm 1: Low dose caffeine
Arm 2: Medium dose caffeine
Arm 3: High dose caffeine
Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 1 neonates will receive low dose intravenous caffeine citrate (5 mg/kg).
Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 2 neonates will receive medium dose intravenous caffeine citrate (15 mg/kg).
Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 3 neonates will receive high dose intravenous caffeine citrate (25 mg/kg).