RecruitingPhase 2NCT07262060

Improving Preterm Kidney Outcomes With Caffeine

Optimizing Caffeine Therapy for Hypoxia in Preterm Neonates: A Randomized Trial Assessing Efficacy, Acute Kidney and Brain Injury, Safety, and Pharmacokinetics


Sponsor

University of Wisconsin, Madison

Enrollment

114 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to see if additional caffeine citrate (20 milligrams per kilogram IV bolus) helps babies with low kidney oxygenation already being treated with caffeine citrate (20 milligrams per kilogram IV bolus on day of life (DOL) 1 followed by 8 milligrams per kilogram daily maintenance). The investigators hypothesize that additional caffeine will improve kidney oxygen levels, while not causing any brain injury, and may reduce rates of acute kidney injury compared to placebo. This study will take place in preterm babies born less than 30 weeks gestational age, with the intervention occurring between greater than 48 hours of age until DOL 14 and outcomes tracked until neonatal intensive care unit (NICU) discharge.


Eligibility

Min Age: 12 HoursMax Age: 96 Hours

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Caffeine citrate and a drug called Placebo for people with kidney injury and pre-term. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Hours to 96 Hours.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCaffeine citrate

intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance

DRUGPlacebo

same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)


Locations(1)

UW Hospital and Clinics

Madison, Wisconsin, United States

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NCT07262060


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