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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days

Awards & highlights

Study Summary

This trial is testing whether it's safe to give caffeine citrate to newborns with a brain injury from lack of oxygen. If it is, this could become a treatment to help protect their kidneys.

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.Check my eligibility

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.See study design

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

Select...

My newborn was admitted to the NICU within 24 hours of birth and was at least 35 weeks gestational age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration-time curve of caffeine

Clearance of caffeine

Peak plasma concentration (Cmax) of caffeine

+3 more

Secondary outcome measures

Acute kidney injury

Renal near infrared spectroscopy (NIRS)

Urine interleukin-18 (IL-18) (pg/mL)

+2 more

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 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).

Group III: 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).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

150,335 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 1: Low dose caffeine, Arm 3: High 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to enroll in this scientific investigation?

"The medical trial will accept 18 neonates, aged 0-24 hours, who have been administered caffeine. Furthermore, these infants must be born at a minimum of 35 weeks gestation and admitted to the ACH NICU within 24 hours after birth. Additionally, any patient receiving therapeutic hypothermia or whole body cooling for hypoxic ischemic encephalopathy according to National Institute of Child Health and Human Development criteria should meet eligibility requirements as well."

Answered by AI

Are geriatric individuals being included in this research endeavor?

"To be eligible for this trial, applicants must fall within the 0 - 24 hour age bracket. Out of all clinical trials available, 112 are specifically tailored to minors and 693 target seniors."

Answered by AI

Are new participants currently being welcomed into the trial?

"According to clinicaltrials.gov, this medication study is not actively seeking participants; the initial posting date being March 1st 2023 and the last update occurring on November 28th 2022. Yet there exist 821 other trials which are currently searching for volunteers."

Answered by AI

Could you elucidate the potential risks of participating in Arm 3: High dose caffeine?

"Arm 3: High dose caffeine is rated a 1 on the risk scale, as this Phase 1 trial has not yet produced sufficient safety and effectiveness data."

Answered by AI

What is the ultimate aim of this experiment?

"This trial's primary goal, measured within a week, is to ascertain the area under the plasma concentration-time curve of caffeine. Additional objectives include assessing Acute Kidney Injury according to KDIGO criteria based on urine output and serum creatinine, Urine interleukin-18 levels in 24/48/72 hour postpartum samples, as well as Renal near infrared spectroscopy value changes during therapeutic hypothermia and rewarming periods."

Answered by AI

Recent research and studies

Pediatric NephrologyJournal

Prognostic Role of Acute Kidney Injury on Long-term Outcome in Infants with Hypoxic-ischemic Encephalopathy

Cavallin, Francesco, Giulia Rubin, Enrico Vidal, Elisa Cainelli, Luca Bonadies, Agnese Suppiej, and Daniele Trevisanuto. 2019. “Prognostic Role of Acute Kidney Injury on Long-term Outcome in Infants with Hypoxic-ischemic Encephalopathy”. Pediatric Nephrology. Springer Science and Business Media LLC. doi:10.1007/s00467-019-04406-4.

The Journal of PediatricsJournal

Acute Kidney Injury in Asphyxiated Newborns Treated with Therapeutic Hypothermia

Selewski, David T., Brian K. Jordan, David J. Askenazi, Ronald E. Dechert, and Subrata Sarkar. 2013. “Acute Kidney Injury in Asphyxiated Newborns Treated with Therapeutic Hypothermia”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2012.10.002.

Therapeutic Drug MonitoringJournal

Population Pharmacokinetics of Caffeine in Neonates and Young Infants

Thomson, A. H., S. Kerr, and S. Wright. 1996. “Population Pharmacokinetics of Caffeine in Neonates and Young Infants”. Therapeutic Drug Monitoring. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00007691-199606000-00005.

NeonatologyJournal