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Improving Preterm Kidney Outcomes With Caffeine
Sponsor: University of Wisconsin, Madison
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
Conditions
Interventions
Caffeine citrate
intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance
Placebo
same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)
Locations (1)
UW Hospital and Clinics
Madison, Wisconsin, United States