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Improving Preterm Kidney Outcomes With Caffeine

This study is looking at whether giving extra caffeine citrate can help improve kidney oxygen levels in very premature babies (born before 30 weeks of pregnancy) who already receive caffeine. Researchers want to see if this additional caffeine citrate (20 milligrams per kilogram given intravenously, or IV) can improve kidney oxygenation and potentially reduce kidney injury compared to a placebo (a salt water solution). You might be eligible if your baby is between 12 and 96 hours old, born very prematurely, and can have special monitoring of brain and kidney oxygen levels. The main goal is to see how many babies show improved kidney oxygenation within 3 hours after receiving the study treatment. The current status of this study is unclear.

Study design
This interventional study plans to enroll 114 preterm babies. Participants with low kidney oxygenation will be randomly assigned to receive either caffeine citrate or a placebo.
What's involved
Participants will receive IV medications and have near-infrared spectroscopy (NIRS) monitoring of their brain and kidney oxygenation. The intervention will occur between 48 hours and 14 days of life, with outcomes tracked until NICU discharge.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be tracked until neonatal intensive care unit (NICU) discharge.

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

NCT07262060

Improving Preterm Kidney Outcomes With Caffeine

Recruiting
PHASE2Ages 12–96InterventionalTreatment
University of Wisconsin, Madison
~114 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Caffeine citratePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with Improvement in Kidney Oxygenation
Measured over Up to 3 hours post-intervention (Between days 1 and 17)

Conditions

Kidney Injury
Pre-Term

Explore related trials

Acute Renal FailurePreterm Birth

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Matthew W Harer, MD · PRINCIPAL_INVESTIGATOR · UW School of Medicine and Public Health

Who to contact

Elena Alfaro, CCRP
[email protected]
(608) 890-0584
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Gestational age at birth between 23 0/7 and 29 6/7 weeks.
Able to have near-infrared spectroscopy (NIRS) monitoring of cerebral and kidney oxygenation.
Able to receive IV medications.
Indwelling umbilical arterial catheter (UAC), umbilical venous catheter (UVC), peripheral arterial line (PAL), or peripherally inserted central catheter (PICC) already in place that can draw blood.
Receiving caffeine at the time of enrollment
Have a birth parent who is at least 18 years old and have a parent or guardian who is able to provide parental permission in English or Spanish

Exclusion

Known or suspected major congenital anomaly of the brain, heart, lungs or kidney (excluding UTD A1 pyelectasis).
Known or suspected chromosomal or genetic anomaly.
Not suitable for study participation due to other reasons at the discretion of the investigators.

What this trial measures

  • Proportion of Participants with Improvement in Kidney OxygenationUp to 3 hours post-intervention (Between days 1 and 17)

    In the 3 hours after receiving the intervention or placebo, participants have kidney oxygenation monitored. Improvement in oxygenation is defined as having 30 minutes where at least 90 percent of measured values are at least 50 percent.