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Methylxanthine

Caffeine Citrate for Newborn Brain Injury

Phase 1
Waitlist Available
Led By Jennifer Rumpel, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newborns ≥ 35 weeks GA admitted to the ACH NICU less than 24 hours of life
Be younger than 18 years old
Must not have
Genetic or congenital condition that affects renal function (e.g., congenital anomalies of the kidney and urinary tract (CAKUT), complex congenital heart disease)
Theophylline, aminophylline, or caffeine exposure prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if caffeine can protect the kidneys of newborns with brain injury due to lack of oxygen at birth. These babies are at high risk for kidney problems, and current treatments are limited. Caffeine might help by improving urine output and reducing kidney damage.

Who is the study for?
This trial is for newborns at least 35 weeks old with hypoxic ischemic encephalopathy, undergoing cooling therapy to treat brain injury caused by oxygen deprivation. Babies can't join if they have genetic conditions affecting the kidneys, severe ongoing seizures, or prior exposure to similar drugs like theophylline.
What is being tested?
The study tests how safe caffeine citrate is for these babies and how their bodies handle the drug. It's a first step in exploring whether caffeine can protect their kidneys during this critical time.
What are the potential side effects?
As it's an early-phase trial focusing on safety and dosage levels, specific side effects are being determined; however, typical caffeine-related side effects may include jitteriness, increased heart rate, and digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My newborn was admitted to the NICU within 24 hours of birth and was at least 35 weeks gestational age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a genetic condition that affects my kidney function.
Select...
I have not taken theophylline, aminophylline, or caffeine before joining.
Select...
I have had a very long seizure or needed many medicines to control my seizures.
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My baby's parents are unable to give informed consent due to diminished capacity or autonomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the plasma concentration-time curve of caffeine
Clearance of caffeine
Peak plasma concentration (Cmax) of caffeine
+3 more
Secondary study objectives
Acute kidney injury
Renal near infrared spectroscopy (NIRS)
Urine interleukin-18 (IL-18) (pg/mL)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Arm 2: Medium dose caffeineActive Control1 Intervention
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).
Group II: Arm 3: High dose caffeineActive Control1 Intervention
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).
Group III: Arm 1: Low dose caffeineActive Control1 Intervention
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).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Acute Kidney Injury (AKI) include fluid resuscitation, diuretics, and renal replacement therapy. Fluid resuscitation aims to restore blood flow to the kidneys, improving perfusion and oxygen delivery. Diuretics help to manage fluid overload and reduce kidney swelling. Renal replacement therapy, such as dialysis, removes waste products and excess fluids when the kidneys are not functioning adequately. These treatments are crucial for stabilizing kidney function and preventing further damage. Caffeine citrate, being studied for its kidney protective properties, may work by enhancing renal blood flow and reducing inflammation, potentially offering a novel approach to support kidney function in AKI patients.

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,619 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
12 Patients Enrolled for Acute Kidney Injury
Jennifer Rumpel, MDPrincipal InvestigatorUniversity of Arkansas

Media Library

Caffeine Citrate (Methylxanthine) Clinical Trial Eligibility Overview. Trial Name: NCT05295784 — Phase 1
Acute Kidney Injury Research Study Groups: Arm 2: Medium dose caffeine, Arm 3: High dose caffeine, Arm 1: Low dose caffeine
Acute Kidney Injury Clinical Trial 2023: Caffeine Citrate Highlights & Side Effects. Trial Name: NCT05295784 — Phase 1
Caffeine Citrate (Methylxanthine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05295784 — Phase 1
~0 spots leftby Oct 2025