drugset / Trial / NCT07262060

Improving Preterm Kidney Outcomes With Caffeine

NCT07262060

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-05-28
Primary completion
2030-03
Completion
2030-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 8 mg/kg Intravenous

Indications