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Theophylline for Kidney Protection in Newborns with HIE

This study is looking at whether giving theophylline (or aminophylline, a similar medicine) to newborns can help prevent kidney damage. Acute kidney injury (AKI) is a serious problem for babies who have hypoxic ischemic encephalopathy (HIE), a type of brain injury from lack of oxygen. Researchers want to see if giving a single dose or repeated doses of theophylline soon after birth can reduce the risk of AKI. You might be able to join if your baby is between 1 and 18 hours old, born at 35 weeks gestation or more, weighs over 1800 grams, has HIE and is receiving cooling treatment, and has no major birth defects. This pilot study aims to enroll 30 infants to see if this approach is possible for a larger future study.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will recruit patients for 2 years, but it's not specified how long individual participants will be followed after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05853601

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

Active, Not Recruiting
PHASE1Ages 1–18InterventionalPrevention
Medical College of Wisconsin
~30 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Single Dose TheophyllineRepeat Dose Theophylline

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment of patients
Measured over 2 years

Conditions

Acute Kidney Injury
HIE

Explore related trials

Acute Renal FailureHypoxic Ischemic Encephalopathy

Where it's being run

1 sites across 1 states
Oklahoma1

Study leadership

  • Jeffrey Segar, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

gestational age at birth \>= 35 weeks by best obstetrical dating
birth weight \> 1800 grams
clinical determination of HIE and treatment with hypothermia being initiated within six hours of birth according to institutional guidelines
no known congenital abnormalities involving the brain, kidneys, heart or lungs
ability to administer theophylline via intravenous route within 18 hours of birth

Exclusion

infants with suspected or diagnosed significant renal, urinary tract, brain, heart, or lung abnormalities
infant with known chromosomal anomaly
evidence of head trauma or skull fracture causing major intracranial hemorrhage
inability to initiate hypothermia within six hours of birth
attending physician unwilling to have infant participate in the study
inability to obtain informed consent within 18 hours of birth

What this trial measures

  • Recruitment of patients2 years

    Examine the ability to recruit and enroll patients in trial. We will assess the number of eligible patients and compare that number to those actually enrolled. This ratio will inform regarding the ability to recruit patients in a larger, randomized, appropriately powered trial.