Status:
WITHDRAWN
PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
Lead Sponsor:
University of Arkansas
Conditions:
Acute Kidney Injury
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
Brief Summary
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia. This study is an essential f...
Detailed Description
Neonatal acute kidney injury (AKI) is an unfortunate comorbidity in neonates with hypoxic ischemic encephalopathy (HIE) which is brain injury due to a lack of blood flow and oxygen delivery to a neona...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05295784
Start Date
May 8 2024
End Date
May 8 2024
Last Update
May 10 2024
Active Locations (2)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205