Improving Preterm Kidney Outcomes With Caffeine

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.

NCT Number	NCT07262060
Lead Sponsor	University of Wisconsin, Madison Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	Kidney Injury, Pre-Term
Enrollment	114 participants
Start Date	2026-05-28
Primary Completion	2030-03 (estimated)
Study Completion	2030-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-04