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NOT YET RECRUITING
NCT07262060
PHASE2

Improving Preterm Kidney Outcomes With Caffeine

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Hours - 96 Hours

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2026-05

Completion Date

2030-09

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

Caffeine citrate

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

DRUG

Placebo

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

Locations (1)

UW Hospital and Clinics

Madison, Wisconsin, United States