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RECRUITING Phase 2 ClinicalTrials.gov

Improving Preterm Kidney Outcomes With Caffeine

Sponsor: University of Wisconsin, Madison • ClinicalTrials.gov ID: NCT07262060

Registry updated: 2026-09-18
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Description

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.

Interventions

  • Caffeine citrate (Drug)
    intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance
  • Placebo (Drug)
    same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)

Eligibility criteria

Inclusion Criteria: * Gestational age at birth between 23 0/7 and 29 6/7 weeks. * Able to have near-infrared spectroscopy (NIRS) monitoring of cerebral and kidney oxygenation. * Able to receive IV medications. * Indwelling umbilical arterial catheter (UAC), umbilical venous catheter (UVC), peripheral arterial line (PAL), or peripherally inserted central catheter (PICC) already in place that can draw blood. * Receiving caffeine at the time of enrollment * Have a birth parent who is at least 18 years old and have a parent or guardian who is able to provide parental permission in English or Spanish Exclusion Criteria: * Known or suspected major congenital anomaly of the brain, heart, lungs or kidney (excluding UTD A1 pyelectasis). * Known or suspected chromosomal or genetic anomaly. * Not suitable for study participation due to other reasons at the discretion of the investigators.

Conditions

Kidney Injury Pre-Term

Locations

  • UW Hospital and Clinics — Madison, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record