See if extra caffeine helps preterm babies with kidney oxygen problems
Official title: Optimizing Caffeine Therapy for Hypoxia in Preterm Neonates: A Randomized Trial Assessing Efficacy, Acute Kidney and Brain Injury, Safety, and Pharmacokinetics
Run by University of Wisconsin, Madison · NCT07262060 · Data updated 2026-11-12
This study tests whether giving additional caffeine to very premature babies with low kidney oxygen levels can improve kidney health without harming the brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Hours to 96 Hours |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | May 28, 2026 |
| Main results expected | May 15, 2030 |
| Study ends | October 15, 2030 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07262060 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm babies born between 23 0/7 and 29 6/7 weeks gestation with IV access and NIRS monitoring, already receiving caffeine, and whose kidney oxygenation drops below 50% within 14 days of life.
✕Probably not a fit
Infants whose kidney oxygenation remains above 50% or who have contraindicating brain oxygenation issues may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial will enroll about 114 preterm neonates less than 30 weeks gestation who are already receiving caffeine for respiratory support. Eligible infants with kidney oxygenation below 50% after 48 hours and within 14 days of life will be randomized to receive either IV caffeine citrate (20 mg/kg) or placebo for 14 days, with outcomes tracked through NICU discharge or 6 months of age. A third non-intervention control group will include infants with normal kidney oxygenation. The study uses near-infrared spectroscopy to monitor brain and kidney oxygenation and compares rates of acute kidney injury between groups while ensuring brain oxygenation remains safe.
Why it matters
Potential benefit: If successful, the approach could reduce acute kidney injury in very preterm babies who have kidney oxygenation challenges.
How similar studies have gone: Prior studies in similar neonatal populations have explored caffeine for organ protection, but this trial investigates an additional dosing strategy for kidney oxygenation, making it relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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UW Hospital and Clinics
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Matthew W Harer, MD — UW School of Medicine and Public Health
- Study coordinator: Elena Alfaro, CCRP
- Email: elalfaro@wisc.edu
- Phone: (608) 890-0584
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.