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Improving Preterm Kidney Outcomes With Caffeine

RecruitingPhase 2Ages 12 Hours - 96 HoursAllUniversity of Wisconsin, Madison
NCT07262060 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Caffeine citrate
  • Placebo
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Where

1 site
UW Hospital and Clinics
Madison, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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