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

What this Trial Is About

Researchers are investigating whether giving extra caffeine citrate to preterm babies with low kidney oxygen levels can improve their kidney oxygenation without causing brain injury. This study focuses on preterm infants born before 30 weeks of gestation who are already being treated with caffeine citrate. The goal is to see if additional caffeine may reduce the risk of acute kidney injury compared to a placebo. The study has three groups: one receiving intravenous caffeine citrate (20 mg/kg as a bolus and then 8 mg/kg daily maintenance), another receiving a placebo of saline solution, and a control group of babies with normal kidney oxygen levels who receive no intervention. Eligible babies will be enrolled between 12 and 96 hours after birth, with treatment starting after 48 hours and continuing until day 14 of life. The study will continue to collect outcomes through discharge from the neonatal intensive care unit (NICU) or until 6 months of age. Participants will undergo brain and kidney oxygen monitoring using near-infrared spectroscopy (NIRS). Researchers will collect blood samples to measure creatinine and caffeine levels and gather urine samples for biomarker analysis. The main measure is improvement in kidney oxygenation within 3 hours after treatment, with secondary outcomes including days with acute kidney injury and brain oxygen levels. All study activities occur during hospitalization in the NICU, with follow-up until discharge or 6 months old.

Improving Preterm Kidney Outcomes With Caffeine