PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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 first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Caffeine; Caffeine citrate

Criteria

Inclusion Criteria:

1. Newborns ≥ 35 weeks GA

2. Admitted to the ACH NICU less than 24 hours of life

3. 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:

1. Genetic or congenital condition that affects renal function (e.g., congenital anomalies of the kidney and urinary tract (CAKUT), complex congenital heart disease)

2. Diminished capacity or autonomy of the neonate's parents that prevents their ability to give informed consent

3. Theophylline, aminophylline, or caffeine exposure prior to enrollment

4. Status epilepticus as defined by:

1. A seizure lasting longer than 30 minutes

2. Use of a continuous infusion of antiepileptic medication (i.e., midazolam)

3. The use of 3 or more antiepileptic medications for the indications of intractable seizures